Reporting to the Director of Quality Control/QA Commercial External Manufacturing the role will provide support for all aspects of QC operations for APIs, Drug Substance & Drug Product ensuring compliance with regulatory guidelines and GMP/quality standards. Through collaboration with business partners the individual in this role ensures that QC support is provided to meet Quality goals & objectives, patient supply, ensure successful outcomes from interactions with Health Authorities and regulatory filings. The Quality Control Specialist of External Manufacturing ensures that appropriate oversight is provided for QC testing at contract testing laboratories and external manufacturing operations. Additional responsibilities will include cross-functional team membership within Jazz Pharmaceuticals.
Responsibilities:
Responsible for developing and maintaining functions of Quality Control and ensures that all 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 resolution of out-of-specification (OOS)/out of trends (OOT) analytical deviations
Provide analytical/technical support to Jazz Technical Operations and External Manufacturing
Ensure that operations within External Manufacturing and contract testing laboratories are compliant with cGMPs and in compliance with regulatory filings.
Lead analytical method transfers/validation programs in compliance with regulatory/Jazz requirements
Troubleshooting of analytical methods
Operate Jazz CAPA/deviation, training and compliance systems
Author, Review and approval of SOPs, analytical validation protocols and reports.
Use of Quality Systems to realize the highest quality standards attainable for all activities conducted by the company.
Maintain Quality 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 all product-related, Quality Technical Agreements (QTA’s).
Support the creation and maintenance of regional and global quality control and laboratory systems in relation to quality control operation.
Actively support QC system improvements to ensure efficient, effective and compliant process
Ensure of compendial method updates implemented as appropriate for Jazz products
Other Responsibilities:
Identify and implement Continuous Improvement programs as appropriate within Jazz Pharmaceuticals
Work closely with other members of Jazz Technical Operations group and External Manufacturers to ensure delivery of key project objectives
Assist with troubleshooting quality control issues at External Manufacturer’s as required.
Maintain appropriate Quality Technical Agreements with all GxP vendors
Supporting regulatory submissions as required
Professional Competencies:
Bachelors of Science, Masters or equivalent in biochemistry, chemistry or a related discipline
At least 3-5 years’ experience working in a laboratory/quality environment within the pharmaceutical industry
Experience in Biologics/Drug product/Drug Substance/APIs is desirable
Demonstrated knowledge of quality systems, FDA and EU guidelines as the relate to analytical testing/product manufacturing
Experience with regulatory inspections
Strong Interpersonal skills and professional skills to interact at all levels including senior management, contractors, and colleagues
Excellent communication and time management skills
