Immediately inform EMP Service Manager if you cannot resolve customer requests and ensure all requests are followed through, Maintain and have available at all times a daily EMP Service Diary/Log, Maintain the EMP Service Product File with all relevant bodies, Obtain and maintain the EMP Service Database of SPC's, PIL's and COA's, Control and process suppliers paper work and collate all relevant data, Ensure that all necessary manufacturing information is recorded in accordance with IMB Regulatory Reporting, Document and Report ADR's (Adverse Drug Reactions) to the EMP Service's Manager and the company's Responsible Person, Document and Report Product Recalls to the EMP Service's Manager and the company's Responsible Person, Comply with all GDP processes and procedures and in particular comply with regulations in force relating to supply of EMPs, Ensure that the EMP Service complies at all times to SOP's and Policies, Assisting in the coordination, implementation and follow up of regulatory agencies, internal audits and customer audits, Provide procurement support for other procured goods as required, To assist with all aspects of administration associated with the commercial team to include sales reports when required, Any other related activities as indicated by the EMP Service Manager, Required: Deep understanding of all issues specific to the supply of EMPs and must have, Previous experience with SAP is a distinct advantage, Flexibility: It is essential that the candidate be able to provide flexibility to the function. Excel, Matlab, Jmp or other programs), General wet lab skills including protein chromatographic characterization (SEC, IEC, RP), UV-visible spectroscopy and colorimetric assays, Perform analysis of samples with a variety of biochemical and biophysical assays including HPLC, ELSD, icIEF, sub-visible particle counting, osmolality, capillary electrophoresis sodium dodecyl sulfate (CE-SDS), Prepare data for presentation and assist in generating technical reports, and interact with other groups within the department, Perform review and peer review of analytical data, Troubleshoot method and instrumentation problems as needed, Initiate and perform investigations and development as needed, Develop and execute validation plans as needed, Strong organizational, scientific, computational, communication and interpersonal skills. Pharmaceutical Industry jobs. This includes timely escalation of discrepancies upon identification, Must be able to work day shift 8 - 5pm Monday - Thursday, Bachelor's of Science degree preferred - Microbiology degree highly preferred, Effective written and verbal English communication skills required, 0-2 years’ experience in a regulated environment, medical device experience preferred, Pharmaceutical or medical device experience a plus, Ability to manage several tasks at the same time; Ability to focus on tasks ; Ability to evaluate operating conditions ; Ability to exercise sound judgment Personal Protective Equipment, Ability to see fine particulate and differentiate colors in liquid solutions, Ability to hear, write (English), and speak (English) clearly in order to communicate in manufacturing setting, Bachelor's degree or higher in a science or engineering discipline from an accredited institution, Experience working in a hospital or clinical setting, Knowledge of Good Clinical Practice (GCP), International Conference on Harmonisation (ICH), and Food and Drug Administration (FDA) guidelines, Excellent ability to multi-task and prioritize, Experience as time served Process Engineer, Experience of working in a pharmaceutical environment, Experience with regulated environment documentation practices, Must be able to lead cross-functional teams in problem solving, development of improvement plans and root cause-analysis, Experience of commissioning and maintenance of complex plant and equipment, Able to read and understand engineering drawings, IT literate (MS Outlook, MS Word, MS Excel,), Degree qualified engineer or equivalent knowledge and experience, Experience of Improvement Projects (lean, Six sigma), Conversant in GE Systems (EMS, G&O’s, E-learning, Concern Reporting), Pre-call plan to meet health care professionals' (HCP) needs. developing and recommending alternative DW technical and data management solutions, methodologies, strategies and architectural improvement plans). better ) in Life Science related field, Working experience in Pharmaceutical Industry, 5+ years of Writing and Editing experience, Bachelor's Degree in English or Communications, Comfortable marking up edits digitally via Adobe PDF, Agency or CME (continuing medical education) experience, Previous experience within the Pharmaceutical industry, Engage physicians and office personnel in live video detail and/or telephonic interactions, Able to influence prescribers in an effort to significantly grow market share, Adhere to regulated guidelines for communications via all channels, Maintain a high level of product knowledge, policies, procedures, contacts, and the medical device industry; continual learning & training as required, Ability to build strong relationships with key staff members and establish relationships with the appropriate personnel in the physician’s office, Ensure timely and appropriate communication occurs with client’s sales and marketing team, Display flexibility and willingness to accept constantly changing project/program updates, Demonstrate corporate values on a consistent basis, Extensive self-study, training and testing are required; eligibility to proceed through training and selling certifications are dependent upon passing required exams, Adhere to all company policies and guidelines, Superior rapport and relationship building skills with the gatekeeper and office personnel, Demonstrated ability to learn, retain, and articulate technical/scientific-product related information and provide unscripted responses on appropriate subject matter, Planning efforts are well thought out and result in directly influencing a strategic selling approach, Responsible for selecting external Shire contractors as well as leading the team managing the day-to-day contractor activities, Responsible for providing strategic guidance regarding drug substance and drug formulation development to Shire project teams, Leads the development of drug formulation with Shire contractors, Leads the manufacturing of drug substances and drug products with Shire contractors, Reviews protocols for manufacturing drug substances and drug products, Writes and/or reviews analytical method development and stability protocols and reviews resulting data, Ensures development of robust chemical and finished product processes through the use of operational excellence tools such as DOE and QbD, Responsible for managing and developing reporting staff, Participates and contributes to Due Diligence assessment of potential product licensing or company acquisition opportunities as required, Delivers CMC Quality Documents (Module 3 and relevant part of Module 2) and supports the QA department by providing regulatory annual updates, ensuring full compliance with relevant regulatory authority quality standards, Leads or contributes to R&D Process improvement initiatives, Participates in Shire Product Strategy and Project Teams. Policies and procedures are continuously reviewed and revised to ensure our company remains efficient and competitive, Candidates must be enrolled in an accredited college throughout the duration of the internship. pre-development or development), Makes staffing recommendations related to laboratory staff and communicates desired forward path to management for endorsement/implementation. ), Work with the other pharmaceutical operators and supervisors in assigned area to establish priorities and meet deadlines, Maintain, clean, and organize work area and participate in safety improvement projects, Perform work, on personal computer (i.e., Business Operating Systems, read and respond to electronic mail in a timely manner, Microsoft Software, etc. Responsible for hiring, coaching and counseling employees, including performance reviews, disciplinary action and terminations, Requisition Management/Pipeline Management which includes candidate screening, as well as database management (consistently reviewing and assessing pipeline for each requisition and dispositioning candidates accordingly), Manage profitability of Account via development of comprehensive, effective and innovative sourcing and selection strategies in order to efficiently attain top level candidates, Develop process improvements, implement solutions and share best practices with account team members and client partners, Lead weekly meetings with hiring managers and account teams to discuss and assess candidate and requisition status and health. Provide technical leadership skill in all activities related to the development of the assigned engineering projects, Industrial experience preferably 10+ years, Successfully demonstrated several years (mini-mum of 3 years) of directly related experience (within relevant industrial setting), Meet quality, quantity and timelines in all assigned projects, Plan, organize, perform and document scientific experiments/plant activities in collaboration with experienced team members if necessary. manufacturing sites) is ensured by you, You identify, evaluate and implement new technologies for formulation and process development or related protein analysis including supervision of students, You contribute to laboratory team capability development, process improvements and `BI safe` concept, You enable and support lab team in detailed planning, execution and interpretation of experiments, Assists the Sr. Partner with organization (Sales / BDMs) to ensure development of programs, tools initiatives to improve performance. Also Check for Jobs with similar Skills and Titles Top Pharmaceutical Industry Hiring Jobs… The goal is to link subject-matter expertise and work experience to a pharmaceutical employer's published job requirements. and product registration packages for local regulatory agencies, Facilitating and leading meetings and maintaining relevant communication with affiliates and local regulatory agency staff throughout the product approval process, Establishing timely updates and maintenance of global product listings, facility registrations, licenses, approvals, and annual registrations, Collaborating with local teams to identify key regulatory requirements for projects and business initiatives, Overseeing/preparing routine reports and regulatory agency communications, Building, updating, and maintaining paper/electronic regulatory document archival systems. Coordinates with creative team to produce program materials. Assists with drafting of revisions to and creation of new SOP’s. This way, you can position yourself in the best way to get hired. Uses the PPE in the right way, according to SOPs, Safety guidelines and training, maintains the PPE in good conditions, Collaborates in investigations on process deviations for the manufacturing area and provides support in the implementation of corrective and preventive actions (CAPAs), Informs Health Services about any medical condition that could impact the performance of, others and/or the product being manufactured, Complies with environmental guidelines, SOPs, training, guidelines, practices, permit’s conditions, event internal notifications as required, monitors’ process parameters to ensure that weight, temperature, pressure, humidity, or others are within limits and in accordance to requirements established in SOPs and lot documentation. We hear you. Maintain daily production sheets and time sheets for team, Take ownership of training and learning to develop high performance competencies such as technical skills, communication skills, and skills to build a team-oriented culture (i.e. Has the ability to see business needs outside of ones own work area and to drive a cross-functional agenda, Excellent written and oral communication skills. Operational excellence, including operations strategy development, implementation, and due diligence, Identifying and addressing client needs: building, maintaining, and utilizing networks of client relationships and community involvement; communicating value propositions; managing resource requirements, project workflow, budgets, billing and collections; and preparing and/or coordinating complex written and verbal materials, Performing as a team leader: supervising teams to create an atmosphere of trust, leverage diverse views, coach staff, and encourage improvement and innovation, Minimum of 5 years experience in project, event or meeting management, at least 2 of which are in procurement required, Knowledge of domestic hotels and destinations required, international a plus, Knowledge of travel supplier operations, overall capabilities/range of services, Program management system experience preferred, especially with an online sourcing tool, Understanding of and ability to effect win/win solutions, Operations experience in hospitality industry or equivalent a plus, Prior successful experience in developing and maintaining key client and supplier relationships, Prior experience in effectively handle multiple projects/demands, Strong knowledge of program/event management and budget maintenance, Ability to travel by airplane, boat, rail and/or car, Contribute to research experiments to 1.) She may have other professional certifications in health care fields, including certifications for operating specialized medical equipment and clearances to perform specialized research on human or animal subjects. Register your CV on and search for jobs in: Pharmaceutical Industry sector in Namibia. Basic knowledge of CTD required, Strong project management skills, understanding of the digital space, including experience with Information Architecture, responsive websites, display campaigns, responsive emails, mobile applications, iPad/Tablet development, and interactive Video, Hands-on involvement in gathering and documentation of business requirements, pre-planning meetings to assess project scope, agency resources, and proper capabilities alignment, Plan timelines and resources, and manage team execution in collaboration with agency peers to ensure project completion on time, on quality and on budget, Develop, drive, and revise timelines, assign resources, manage route and timely approvals for all tactics/deliverables using workflows and follow up directly with resources in person as needed, Manage agency internal resources (strategy, copywriting, design, user experience, development, QA) and contribute ongoing digital insights to ensure digital solutions meet client expectations (KPIs), Prepare status reports and prioritized hot sheet communications, setup and lead internal meetings, capture internal meeting minutes and next steps, and update all stakeholders as required, Maintain up-to-date and organized files for all stages from concepts to completed pieces, Manage project utilization and review monthly reports, ensure overall project financial health, Evaluate programs to identify potential risks and prepare action plan, implement solutions, document “issues logs”. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position, The qualified candidate will have level appropriate relevant experience in pharmaceutical product development, clinical development, engineering, manufacturing, discovery, business leadership or product design. Formulates and tracks action plans to address issues, opportunities and associated CAPA, Develops, reviews and manages department capital and expense budgets. Keep abreast of industry standards and trends related to responsibilities, Minimum of 5+ years experience in event or meeting management required. ), The incumbent may perform such metrology functions as instrument/system calibration and qualifications, 3-5 years of experience in the pharmaceutical industry, The incumbent must demonstrate excellent verbal, written and interpersonal communications skills, In that there are stringent requirements associated with the pharmaceutical industry a high degree of accuracy, commitment and integrity is required, The incumbent should exhibit proficiency in software such as Microsoft Word and Microsoft Excel, Please submit resume directly to the posting, Writes technical documents such as methods, specifications, validation protocols and reports, transfer protocols and reports based on corporate policies and SOPs, compendial, ICH and FDA regulatory guidance, Ensures that the integrity and accuracy of all laboratory documents are maintained, Assess overall document compliance with protocols, SOPs, company policies, and applicable regulations, Evaluates compendial documents and reviews procedures for analytical development and validation, Reviews Drug Master Files (DMFs) of active ingredients and provides essential information to laboratory personnel, Reviews analytical data for accuracy, completeness and compliance to cGMPs and established laboratory documentation standards, Generates change requests required for analytical documents and routes documents for review and approval. Did documentation preparing (complied with GaMP5 and ICH Q9 Quality Risk Management), Knowledge on pharmacy process (familiar with one or two typical process), Understand pharmacy industry control project requirement, Minimum 5 years of pharmaceutical batch project or Pharmacy factory DCS system maintenance experience, Computer science fundamentals (OOPS, Operating System, Data Structure, Office), Knowledge on Microsoft SQL Server 2000 / 2005 / 2008, VB,VC++ preferred, Willing to study & Learn new technologies on demand through websites and implement the same as per the project requirement in Batch project domain, Knowledge on testing methods will be an added advantage, Develop and execute manufacturing work plans/schedules for self and team, using customer milestones and Division/site performance standards and metrics, Independently authors and approves technical documents, such as protocols, technical reports, test methods and operating procedures, Review technical documents for accuracy, thoroughness and regulatory compliance, Trains, coaches or mentors others on technical, personal development or business issues, Supervises technical staff, including work assignments and performance and development management, Responsible as project director on multiple projects, with responsibility for project outcome and customer interaction, including developing customer relationship to grow the business, Identifies and independently drives department level improvements, Identify and recommend business strategies for multiple customers across multiple company sites, Manages professional employees and/or supervisors, Is accountable for the performance and results of a team within own discipline, Adapts departmental plans and priorities to address resource and operational challenges, Decisions are guided by policies, procedures and business plan; receives guidance from manager, Provides technical guidance to employees, colleagues and/or customers, Uses leading-edge knowledge of principles, concepts and practices and/or techniques to lead complex projects within a department/ group/team that may involve related departments/groups/ teams, Applies technical, functional, business and/or industry knowledge to design experiments/projects, Provide scientific consultation to the department/ discipline/group, Actively contributes to the strategic direction of the department/ group by recommending expansion or curtailment of investigations on the basis of experimental results or scientific information, Maintain high quality documentation in accordance with applicable regulatory guidance and Site SOPs, Experienced in most aspects of drug development and lifecycle support, and able to develop useful strategies and tactics to meet regulatory milestones, Has substantial breadth/depth of technical acumen in multiple techniques with significant expertise in one or more techniques and can understand their application in context of pharmaceutical services offerings, Capable of rapid learning of multiple unfamiliar principles or techniques with minimum training, Is able to lead difficult discussions with customers and drive the conversation to an acceptable resolution, Recognized by internal and external customers and direct reports as a subject matter expert with high personal credibility, Can assess training needs and formulate development plans for direct reports, Works directly with Business Development to win new business (conference calls, new customer meetings, some travel), Ability to interpret, provide and manage a variety of instructions furnished in written, oral, diagram, or schedule form across multiple work groups and departments, Understands the details of regulatory CMC filing package and the analytical and formulation documentation required therein. 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