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.

SOPS and Guidance documents

Review and approval of different department (FD, AD, DQA, Store etc.) SOPs and guidance.
Track the effectiveness of SOPs/Guidances 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
Masters 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.

General Manager