Position : AM/DM - Documentation
Location : Baska, Halol

Position Overview :
Candidate should have experience of Injectable formulation development and technology transfer from R&D; scale to large scale for regulatory market projects (US and EU)
Job Requirements and Responsibilities:
- Literature search for ongoing projects, data collection, Literature summary reports,
- Should have update for current regulatory guidance and training to F&D; team.
- Good Understating of US-FDA, EMA, ICH guidance.
- R&D; protocols and report reviews such as Compatibility, Photo stability, freeze thaw, stability, reconstitution and dilution stability, external studies.
- Coordination with internal and external teams for protocols and reports.
- Preparation and review MFRs, QbD documents (QTPP, CQAs, CMAs, CPPs)
- Preparation and review of Product specification and PDR/Technical summary reports
- Preparation and review of scientific justifications/technical justifications for regulatory queries.




- Handling of regulatory deficiency and coordination with regulatory team
- Preparation of product development reports (PDR) as per regulatory requirements and ICH guidance.
- Ensure the R&D; documentation as Good documentation Practice (GDP)
- Implementation of digitization of documents and records.
- Implementation of E-Lab Note Book

Skills & Qualification:
- Should have good knowledge of QbD, DOE, Minitab, Design expert software.
- Should have positive understating of Statistical tools required for data processing and interpretation.
- Should have valuable Understating of research paper drafting and publications.
- Should have good Understanding of patent search and patent reading
- Minimum 6-8 years experience required.
- Qualification - B.Pharm, M.Pharm, Ph.D (preferred)

📌 Documentation Manager (Baska)
🏢 BDR GROUP
📍 Baska