Role & responsibilities :

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 valuable 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

📌 Sr Executive / Executive Plant Regulatory Affairs Pithampur (India)
🏢 GUFIC Group
📍 India