Experience - 10 to 16 years
Qualification - M.Sc. (Chemistry)
RESPONSIBILITIES
- Review change controls, OOS, deviations, and other quality system investigations provided by QC / Analytical departments at the site and other locations and send the same for corporate approval.
- Review vendor qualification documents, including vendor questionnaires and interact with the related departments to ensure documentation is complete as per the requirements.
- Prepare and issue CQA guidelines to all sites and maintain all CQA documentation in line with good documentation practices.
- Review SOPs of corporate departments and provide recommendations for improvement.
- Review cleaning validation, method transfer and method validation protocols and reports, stability protocols, QC equipment qualification documents and provide recommendation for improvements.
- Ensure support to review QC labs/analytical labs at all locations and confirm their compliance with GLP.
- Review of audit trial of QC instruments and backup requirement.
- Ensure approval of change controls, deviations, validation protocol / reports & other quality system investigations etc. provided by other locations including corporate departments in absence of Head / Manger CQA.
- Ensure vendor audits, contract testing lab audits as per annual audit planner as and when required.
DESIRED SKILLS
- Experience in handling of change control, OOS, OOT, deviation and vendor qualification.
- Experience in QC team in a reputed pharmaceutical organization.
- Sound have excellent knowledge of method validation, method transfer and cleaning validation.
- Good interpersonal, communication and problem-solving skills
- Should be assertive, proactive and self-driven.
- Ability to work in a fast-paced, demanding, timeline-driven environment