QA Supervisor

Job Overview:
We are looking for an experienced Quality Assurance Supervisor with a strong background in quality assurance for aseptic pharmaceutical products. The successful candidate will play a vital role in overseeing the QA team and ensuring that our products meet the highest standards of quality and compliance with Good Manufacturing Practices (GMP). This position requires a proactive individual who can mentor team members and drive continuous improvement within the QA function.

Key Responsibilities:

1. 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.
2. 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.
3. Analytical Test Method Verification: Lead the verification process of analytical test methods, ensuring rigorous standards are met and maintained.
4. Compendium Test Method Verification: Ensure the review and verification of compendium test methods (USP, EP, JP, etc.) are thoroughly conducted.
5. 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.
6. Technology Transfer Management: Oversee and support the transfer of analytic technology for test methods and guide the preparation of validation documents in English.
7. Environmental Monitoring and Effectiveness Evaluation: Lead environmental monitoring trend analysis and evaluate disinfectant effectiveness for aseptic processes, ensuring a sterile quality environment.
8. GMP Compliance Enforcement: Ensure strict adherence to Good Manufacturing Practices, conducting regular audits and inspections to identify and resolve compliance issues.
9. Documentation Leadership: Write, review, and approve validation master plans, validation plans, SOPs, and other crucial validation documentation, ensuring they are fit for purpose.
10. Validation Protocol Development: Oversee the preparation of validation plans and protocols for production processes, including process validation, cleaning validation, and filtration validation.
11. 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.
12. Continuous Improvement Initiatives: Identify opportunities for process improvements and implement best practices within the QA team to enhance efficiency and effectiveness.

Qualifications:

1. Bachelor’s degree in Life Sciences, Chemistry, or a related field.
2. Over 5 years of experience in quality assurance or validation in a pharmaceutical company, with specific experience in aseptic pharmaceutical products.
3. In-depth knowledge of GMP and regulatory requirements applicable to sterile product manufacturing.
4. Demonstrated leadership skills and experience managing a team.
5. Exceptional written and verbal communication skills in English.
6. Strong problem-solving abilities and analytical skills.

Preferred Qualifications:

1. Experience with international regulatory submissions for aseptic products.
2. Certification in Quality Assurance or related fields is preferred.