Acting as one of the core team members in HMP New DP Plant Project, provide frontline participation in the design, development, qualification and validation of GMP related systems, including laboratory areas meeting cGMP requirements from China, US and EU regulations. Where necessary, manage contractor in various qualification and validation activities.
- Provide Quality oversight (including technical requirements and regulatory expectations) of site qualification and validation efforts.
- Review/generate key qualification/validation lifecycle deliverables and make sure compliance with in effective procedures.
- Ensure all global and site local SOPs are strictly followed.
- Frontline participation and facilitation in risk-based activities (e.g. impact assessment, risk assessment).
- Responsible for qualification/validation program ownership, execution and documentation.
- Maintain and update corresponding validation plan in responsible area(s).
- Maintain and update corresponding inventory list in responsible area(s).
- Collaborate with Project team as well as departments to ensure validation activities are executed compliantly, with efficiency and effectiveness
- Collaborate with departments to ensure risk management, qualification and validation activities are executed efficiently and effectively.
- Responsible for maintenance of qualified/validated state, provide oversight in periodic review.
- Take initiative to support optimization/establishment of qualification/validation relevant SOPs.
- Support in deviation, change control and CAPA management.
- Couching, per pre-established external personnel management procedure.
- Bachelor and/or advanced degree within Pharmacy, Chemical with at least 5 years practical experience in the Pharmaceutical/biotechnology industry.
- Experience in process validation, cleaning validation, equipment/instrument qualification, computer system qualification.
- Know-how in qualification and validation establishment, deployment and maintenance.
- Expert in qualification & validation project execution and operation, schedule management.
- New plant project experience is required.
- Fluent oral & written English skill is required.
- Background in international big pharma is preferred, either project experience or working experience.
- Experience in IT system related qualification/validation project is preferred.
- Experience in DI related topic is preferred.