1. Preparation and revision of QA SOPs and always keep it current.
2. Review SOPs and Work instructions of other departments and verify compliance.
3. Issuance, retrieval and tracking of QMS documents across the site.
4. Tracking and facilitating timely completion of QMS events (e.g., Change control, deviation, OOS, CAPA) and related documentation.
5. Update of Site Master File (SMF) with necessary changes as and when required.
6. Preparation of documents such as Validation Master Plan and report, annual product review.
7. Communicate with external service providers on the qualification of new service provider, technical agreements, audit schedule etc.
8. Identify and implement process improvement opportunities, cost improvement, and monitor the effectiveness of the same.
9. Preparation of validation related documents (e.g., User Requirement Specification, Design, Installation Operational, Performance Protocol of equipment, utilities & facility).
10. Participate in periodic reviews to ensure that business and regulatory requirements are met.
EDUCATION & EXPERIENCE
- Diploma or Degree in Life science or equivalent.
- Experience in a regulated industry preferred.
- A minimum of 3-5 years’ relevant experience in pharmaceutical manufacturing environment.
- Proficient in the use of Microsoft Word, Excel, Access, PowerPoint, and Explorer.
