We are looking to hire a GM - Developmental Quality Assurance professional part of our R&D based out of Thane.
Detailed JD:
Development Documentation Management
- Approval of MFC, MPC, Specifications, STP, Stability Protocols, Product specific study Protocols, Product Development Reports, Technology Transfer Documents etc.
- Approval of various validation study protocols and reports.
- Approval of various Analytical Method Validation Studies.
Handling of QMS Elements
- Review of various QMS elements like Change Control, Deviations, Investigations, CAPA, OOS/OOT, incidents, market complaints, annual product review and other quality system related documents.
- To provide necessary support/investigation for QMS events related to R&D products, pilot batches, exhibit batches and developmental studies at lab 03, Thane.
- Review of various executed documents of exhibit batches manufactured at Various CMOs.
- Review of CMO QMS documents and ensure for the timely closure of QMS documents.
Regulatory Compliance
- Ensure ongoing compliance of the FDA-compliant laboratory with applicable regulatory and quality requirements.
- Review for adequacy of the submission documents e.g., Q1, Q2 Assessments, Study Exemption requests, PDRs, Query responses and product specific data generate at various CMOs etc.
- Review of documents of BA/BE Studies of various products.
- Management of FDA queries, developing responses with RA, CAPA for preventing recurrence of comments for subsequent products.
- Review of various executed documents of exhibit batches prior to regulatory submission for ANDA consideration.
SOP'S and Guidance documents
- Review and approval of different department (FD, AD, DQA, Store etc.) SOP's and guidance.
- Track the effectiveness of SOP's/Guidance's and ensure necessary revisions on need basis as part of system improvement.
BA/BE batch documents review, batch monitoring and release
- Review and approval of master and executed BMR/BPR, Review of Coa and Release of BA/BE batch.
Qualification of equipment in R&D department
- Area and equipment/instrument qualification at R&D site.
- Review of qualification protocols and reports of equipment.
- To support quality activities as and when requires and to support manufacturing plant as and when requires. Top of Form
Must-Have Skills:
- Worked in R&D setup either in formulation or analytical development
- Exposure to various regulatory bodies like US FDA, MHRA, TGA
- Exposure to specific dosage forms like OSD, Liquid Orals
- Team coordination and work distribution
- Exposure to QTAs , PDRs, Risk Assessment
- Master's in chemistry, Biochemistry, B Pharmacy or related field.
- At least total of 10 experiences in DQA, QA and or R&D
- Expected to work in all shifts.
- Expected to visit Satara/ Ambarnath/ Indore sites at least once a month on need basis.
