Leadership and Supervision: Oversee the QA staff, providing guidance and mentorship. Foster a team-oriented environment while ensuring that team objectives align with overall quality objectives.

Quality Assurance Oversight: Direct and manage all quality assurance activities related to the production of aseptic pharmaceutical products. Ensure that all processes, procedures, and products comply with regulatory requirements.

Analytical Test Method Verification: Lead the verification process of analytical test methods, ensuring rigorous standards are met and maintained.

Compendium Test Method Verification: Ensure the review and verification of compendium test methods (USP, EP, JP, etc.) are thoroughly conducted.

Regulatory Guidance Review: Analyze and monitor guidance and regulations regarding product approval and registration in various international markets. Manage the registration statuses for targeted countries.

Technology Transfer Management: Oversee and support the transfer of analytic technology for test methods and guide the preparation of validation documents in English.

Environmental Monitoring and Effectiveness Evaluation: Lead environmental monitoring trend analysis and evaluate disinfectant effectiveness for aseptic processes, ensuring a sterile quality environment.

GMP Compliance Enforcement: Ensure strict adherence to Good Manufacturing Practices, conducting regular audits and inspections to identify and resolve compliance issues.

Documentation Leadership: Write, review, and approve validation master plans, validation plans, SOPs, and other crucial validation documentation, ensuring they are fit for purpose.

Validation Protocol Development: Oversee the preparation of validation plans and protocols for production processes, including process validation, cleaning validation, and filtration validation.

SOP and Record Keeping Management: Develop and evaluate SOPs, Work Instructions, and Forms, and supervise the implementation of a record-keeping system to track all QA activities.