Qa Manager Biologics
Yours Responsibilities
- Serve as the QA expert for assigned biological products.
- Oversee the quality of assigned Clinical and Commercial CMOs, including compliance and performance monitoring.
- Manage quality throughout the lifecycle of assigned projects, from development and process / method validation / transfer to registration and commercialization.
- Make batch disposition decisions after thoroughly reviewing batch documentation.
- Collaborate with the other departments for batch confirmation and certification in relevant markets.
- Maintain and control Product Batch records and databases.
- Manage and approve deviations, OOS, investigations, CAPAs, and Change Controls promptly.
- Conduct quality reviews of stability data for products under their scope.
- Establish and maintain Quality and Technical Agreements with assigned Clinical and Commercial CMOs.
- Support the maintenance of the Quality Management System, focusing on biologics-related SOPs.
- Perform internal and external audits as a qualified auditor, review and approve responses, and ensure CAPA follow-up with concerned CMOs.
- Provide QA support to the RA-CMC group for regulatory submissions and follow-ups.
- Implement Quality Risk Management to identify and mitigate risks related to product quality, safety, and GMP compliance of the assigned CMO.
- Interpret and implement GMP, general regulatory requirements, and Quality systems regulations in manufacturing.
Your Qualifications :
- Master's degree in natural or applied sciences (Pharmacy, Chemistry, Biotechnology, Engineering).
- Minimum 5 years of experience in Quality Operations for pharmaceuticals.
- Expertise in manufacturing and testing biotechnology products.
- Experience overseeing Contractor Quality.
- In-depth knowledge of cGMP and regulatory requirements
- Proven ability to write technical documents, such as APQR.
- Track record in project management as a project team member, able to contribute to multiple ongoing projects.
- Knowledge of technical transfer requirements for Biologics.
- Strong interpersonal skills.
- Excellent verbal and written communication skills, with a well-structured communication and presentation ability.
- Commitment to continuous improvement.
- Results-oriented, with skills in negotiation, empathy, diplomacy, and common sense.
- Fluent in written and spoken English (company language).
- Willing to travel up to 20%.
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