Your role:
General
Responsible for planning and managing Quality oversight & operational activities for contract manufacturing operations (CMOs), ensuring adherence to both compliance standards and business objectives while proactively preparing for upcoming demands.
The role also entails active collaboration with both internal teams and external partners to maintain and enhance quality and regulatory compliance for products on the market.
This position is pivotal in guaranteeing that product performance and quality are in line with predefined criteria and regulatory requirements to safeguard patient health.

Key Accountabilities
• As Delegation Qualified Person to be responsible for Batch Disposition. Review the batch documentation according to the predefined requirements, performs Batch Certification and authorizes the Batch COA/COC, ensure that the production and testing of each batch of released products are in accordance with the relevant marketing authorization, the registration requirements and specifications.
• Manage all quality records & documents related to CMO according to company Governance, respective quality system, Quality Agreement and ensure the compliance (i.e. but not limited to Deviation, Change Control, Investigation, etc)
• Ensure that all pharmaceutical products manufactured by External Manufacturer are certified according to GMP requirements and specifications.
• Drive timely periodic quality review and risk assessment of CMO management and ensures the compliance and appropriate corrective & preventive actions are identified and implemented.
• Responsible for development, availability, and compliance of Product Quality Reviews.
• Participates in and provides support to cross-functional teams in relation to product investigation, regulatory audits/inquires, implementation of new/revised GxP guidelines and improvement initiatives.
• Develop and implements appropriate standards and practices for quality of contract manufacturing operations and ensures alignment with industry best practices.
• Ensures alignment with PQS for implementation of GxP activities with a focus on external GMP manufacturing for commercial products.
• Provide QA support for interdepartmental project work to ensure on-time deliverables and adherence to team resources.


Who you are:
• BS in Pharmaceutical Engineering/Biopharmaceutical
• Minimum 5 years of experience in the pharmaceutical / biopharmaceutical industry, medical, or life sciences required.
• Demonstrated ability to work across matrix organization in international and multi-cultural environment.

• Experience working with external partners (e.g., contract manufacturing organizations, contract laboratories and suppliers) is preferred.

• Good understanding of external compliance trends and ability to address needs based on external demand.

• Strong knowledge of technical writing and project management skills.

• Excellent organization and presentation skills.

其他信息

行业要求：全部行业
所属部门：Quality