Job responsibilities:
- Preparation and revision of QA SOPs and always keep it current.
- Review SOPs and Work instructions of other departments and verify compliance.
- Issuance, retrieval and tracking of QMS documents across the site.
- Tracking and facilitating timely completion of QMS events (e.g. Change control, deviation,OOS, CAPA) and related documentation.
- Update of Site Master File (SMF) with necessary changes as and when required.
- Preparation of documents such as Validation Master Plan and report, annual product review.
- Communicate with external service providers on the qualification of new service provider,technical agreements, audit schedule etc.
- Identify and implement process improvement opportunities, cost improvement, and monitor the effectiveness of the same.
- Preparation of validation related documents (e.g., User Requirement Specification, Design,Installation Operational, Performance Protocol of equipment, utilities & facility).
- 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.
