Review of all QMS documents related to regulatory submissions
- Prepare status of all documents related to submission
- Co-ordinate with all stakeholders of plant for collection of documents
- Provide all regulatory documents to HO-RA for submission.
- Evaluation of change control, deviations and out of specifications.
- Review of specifications, BMRs, BPRs, COA, Method transfer report, Method verification/validation report, Analytical chromatograms, Sterility assurance data package.
- General Review of plant equipment qualifications, filter validation documents and layouts for its adequacy to support regulatory submission.
- To facilitate LoA, Debarment certificate,
GMP certificate with Internal Teams and for external labs / manufacturing facility in collaboration with vendor qualification and/or supply chain team
- Support plant team for all regulatory audit
- Communicate with customer regulatory team for document submission and change control approval.
- Guide plant team for good documentation practice requirement for submission
- Respond all queries of customer on time
- Evaluate all post-approval changes and prepare variation package and share with client
- Positive communication skills and drafting of dossier
- Well aware about Microsoft (Word, Excel and Power point) skills