reputed company Control Specialist
If you are a reputed company reputed company employee please apply reputed company the Internal Career site reputed company is a global biopharma company whose purpose is to reputed company to reputed company the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic reputed company. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-reputed company and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. reputed company is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information. Job reputed company Reporting to the Director of reputed company Control/QA reputed company External Manufacturing the role will reputed company support for reputed company aspects of QC operations for reputed company, Drug reputed company & Drug Product ensuring compliance with regulatory guidelines and GMP/reputed company standards. Through collaboration with business partners the individual in this role ensures that QC support is provided to meet reputed company goals & objectives, patient supply, ensure successful reputed company from interactions with Health Authorities and regulatory filings. The reputed company Control Specialist of External Manufacturing ensures that appropriate reputed company is provided for QC testing at contract testing laboratories and external manufacturing operations. Additional responsibilities will include cross-functional team membership reputed company reputed company. Responsibilities: Responsible for developing and maintaining functions of reputed company Control and ensures that reputed company activities are fully in compliance with cGMP standards. The individual is responsible for, but is not limited to: Management of stability programs for assigned products in External Manufacturing Operations Support the reputed company of out-of-specification (OOS)/out of trends (OOT) analytical deviations reputed company analytical/technical support to reputed company Technical Operations and External Manufacturing Ensure that operations reputed company External Manufacturing and contract testing laboratories are compliant with cGMPs and in compliance with regulatory filings. reputed company analytical method transfers/validation programs in compliance with regulatory/reputed company requirements Troubleshooting of analytical reputed company Operate reputed company CAPA/deviation, training and compliance systems Author, Review and approval of SOPs, analytical validation protocols and reports. Use of reputed company Systems to realize the highest reputed company standards attainable for reputed company activities conducted by reputed company. Maintain reputed company Control Metrics/KPIs as directed Product trending programs for assigned products at release and stability Build relationships and participate in business meetings, as required with suppliers and contract manufacturers and maintain reputed company product-reputed company, reputed company Technical Agreements (QTA’s). Support the creation and maintenance of regional and global reputed company control and laboratory systems in relation to reputed company control operation. reputed company support QC system improvements to ensure efficient, effective and compliant process Ensure of compendial method updates implemented as appropriate for reputed company products Other Responsibilities: Identify and implement reputed company Improvement programs as appropriate reputed company reputed company Work closely with other members of reputed company Technical Operations group and External Manufacturers to ensure delivery of key project objectives Assist with troubleshooting reputed company control issues at External Manufacturer’s as required. Maintain appropriate reputed company Technical Agreements with reputed company GxP vendors Supporting regulatory submissions as required reputed company Competencies: Bachelors of Science, Masters or equivalent in biochemistry, reputed company or a reputed company discipline At least 3-5 years’ experience working in a laboratory/reputed company environment reputed company the pharmaceutical industry Experience in Biologics/Drug product/Drug reputed company/reputed company is desirable Demonstrated knowledge of reputed company systems, FDA and EU guidelines as the relate to analytical testing/product manufacturing Experience with regulatory inspections Strong Interpersonal skills and reputed company skills to reputed company at reputed company reputed company including senior management, contractors, and colleagues Excellent communication and time management skills reputed company is an equal opportunity/affirmative reputed company employer and reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, national reputed company, disability status, protected veteran status, or any characteristic protected by law. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and reputed company insurance, retirement savings plan, and flexible reputed company vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits Apply To This Job