- Reporting to the Director Quality Assurance. Responsible for performing key Quality tasks in respect of Company products.
- Work in the Quality Group within the Technical Operations department, which oversees contract manufacturing operations, select supply chain operations and development functions.
Responsible for developing and maintaining Quality Systems and to ensure that all operations are fully in compliance with current international standards for cGMP.
The individual is responsible for, but is not limited to:
- Managing the product stability programme
- Investigating out-of-specification (OOS) reports & deviations
- Act as lead auditor in third party vendor audits, to include: GMP contract manufacturing, analytical testing, and storage locations when required to ensure compliance with company requirements and country specific regulations.
- Monitor the operations at the Contract Manufacturer. Perform batch review, review product complaints, deviations, change controls and product related investigations.
- Be a key member of company audit team during regulatory or customer audits.
- Support the product complaints system
- Operate the CAPA system
- Develop and write SOPs & controlled documents.
- Implement and improve Quality Systems to realize the highest quality standards attainable for all activities conducted by the company.
- Report Quality Metrics
- Review and approval of product artwork
- Assisting in preparation of Annual Product Reviews
- Build authentic relationships and participate in business meetings, as required, with suppliers and contract manufacturers and maintain all product-related, Quality Technical Agreements (QTA’s).
- Other Responsibilities:
- Work directly with other key Company departments to ensure compliance and productive working relationships.
- Work closely with other members of Technical Operations group to ensure delivery of key project objectives and timelines
- Contribute to management of the supplier approval programme and to maintenance of the external audit schedule.
- Assist with troubleshooting quality issues at Partner’s or vendor’s site or associated with technology transfer, when required.
- Maintain appropriate Quality Technical Agreements with all GxP vendors
- Supporting regulatory submissionsProfessional Competencies:
- Bachelor’s degree in chemistry, biology or a related discipline
- Experience working in finished product pharmaceutical / biologics, including analytical chemistry, quality assurance, quality control, development, and /or manufacturing areas
- Experience with third party vendor auditing, out of spec investigations, change control
- Thorough understanding of quality systems and cGMP’s
- Interpersonal skills and professional skills to interact at all levels including senior executives, contractors, and colleagues
- Experience working with contract manufacturing
- Experience interfacing with regulatory bodies or working on regulatory submissions