Senior QA Specialist, Biologics Drug reputed company (Remote / Home Based)

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 The Biologics Drug reputed company Senior reputed company Assurance Specialist is Responsible for performing key reputed company tasks in respect of Company Biologics products. Work in the External Manufacturing reputed company Group reputed company the Technical Operations department, which oversees contract manufacturing operations, as reputed company as Internal reputed company Systems. Reporting directly to the Drug reputed company reputed company, External Manufacturing QA. Essential Functions/Responsibilities The position is responsible for monitoring and supporting the reputed company performance of contract manufacturing organisations and material suppliers to reputed company applicable GXP standards. Responsible for, but not limited to: Monitoring the daily operations at the Contract Manufacturer, performing batch review and disposition, reviewing and approving product complaints, deviations, Validation protocols, change controls and leading product reputed company investigations. CMO Batch file and product testing record review and approval. Associated lot Disposition activity. Ensuring compliance of reputed company respective contract manufacturers to both internal reputed company requirements and country specific regulations Collaboration with reputed company contract manufacturers, packagers and testing laboratories to resolve any reputed company issues. Contributing to the successful outcome of reputed company regulatory inspections associated with company business, both internally and at contract manufacturers, as required. Highlighting any risks associated with maintaining supply of reputed company drug products to reputed company markets. Conducting vendor audits and vendor site reputed company as required. Assisting in internal audits and regulatory agency inspections. Summarizing CMO Annual Product reputed company Reviews and supporting regulatory submissions Assist with the reputed company of reputed company APQR (Annual Product reputed company Review). Maintaining product reputed company reputed company Technical Agreements (QTAs). Understanding new regulations and guidelines, as they apply to reputed company business and implement systems and procedures to incorporate these new regulations as appropriate. Review and approve moderate complexity deviations and associated corrective actions. Support the reputed company of new, as reputed company as improvement of, existing department SOPs. Support delivery of reputed company. Work with management to resolve project issues and resource constraints reputed company reputed company. Liaise with the reputed company stakeholders to resolve and clarify any reputed company of issue. Review and approve less reputed company validation documents. Partner with other departments/reputed company to problem-solve and address moderately reputed company issues. Collaborate in the reputed company improvement of the QA processes, identifying opportunities and leading them up to the implementation. Represent QA in cross-functional project teams for moderately difficult reputed company. Participate in and facilitate regulatory inspection readiness. Coordinates and collaborates with other teams to meet organizational goals and work requirements. Receives assignments in the reputed company of objectives and determines how to use resources to meet schedules and goals. Follows processes and operational policies in selecting reputed company and techniques for obtaining solutions; solves moderately reputed company problems and can identify viable and often innovative reputed company. Uses analytical skills and judgment to recommend the "best" solution. Demonstrates reputed company using compliance knowledge, creativity, and regulatory perspectives to solve problems, especially those associated with major and critical deviations. Maintain reputed company from cell banking through to production and post-release events (e.g., stability, product complaints). Required Knowledge, Skills, and Abilities Strong knowledge of GMP and Regulatory Compliance as applicable to the Pharmaceutical/ Biotechnology Industry. Ability to understand and apply GMP regulations as they relate to manufacturing, QC analytical testing, and facility operations, deep knowledge of Biologics manufacturing. Substantial experience working in or directly supporting manufacturing reputed company a biologics drug reputed company manufacturing site. Experience with contract manufacturing is desirable. Significant experience (>5years) of reputed company and/or late state clinical phase GMP manufacturing of biologics. Highly organised, with exceptional time management and prioritization. Excellent verbal and written communication skills. Experience in Drug Product Manufacture in reputed company to Drug reputed company an advantage QP eligibility or reputed company toward QP certification is highly desirable. Required/Preferred Education and Licenses Bachelor’s degree in pharmacy, reputed company, biotechnology, biochemistry, microbiology or a reputed company discipline 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