MANAGER – CORPORATE QUALITY
About Inventia Healthcare:
Inventia Healthcare is a pioneer in pharmaceutical development and manufacturing, with over 40 years of expertise in Oral Solid Dosage (OSD) forms. Our global presence spans 45 countries with over ten international facility approvals. Backed by Platinum Equity, we continue to innovate and grow with a strong R&D base in Thane and manufacturing in Ambernath.
JOB DESCRIPTION
ROLE OVERVIEW:
This job role involves reviewing, preparing, issuing, and approving product specifications for finished, semi-finished, and raw materials in OSD across regulated, semi-regulated, and domestic markets. It includes managing change controls, deviations, and compliance with pharmacopeia requirements, while supporting audits, regulatory submissions, and new product launches. The role also covers risk assessments, dossier reviews, and maintaining master records to ensure alignment with corporate quality standards.
KEY RESPONSIBILITIES:
- To review of DCR's for Finished product, Semi finished product & Raw material specifications for regulated, semi regulated and domestic market through DMS for OSD.
- To prepares Finished product, Semi finished product & Raw material specifications and its issuance, distribution and retrieval for regulated, semi regulated and domestic market through DMS for OSD.
- To review & Approve Finished product, Semi finished product & Raw material specifications for mandatory reviews or revisions with respective to Pharmacopeia and its issuance, distribution and retrieval for regulated, semi regulated and domestic market through DMS for OSD for Corporate Quality & ARD.
- To Raise Change controls for revision in Finished, Semi finished product & Raw material
specifications as per pharmacopoeia or any changes respect to Harmonization of
Specification.
- To follow up for closing & comments for Change control proposal, Deviations and FIR with ARD, FRD & Site QA.
- To comment in CCP's, Deviations and FIR for Corporate Quality Specification for OSD as applicable.
- To support to Site for Audit Related requirements.
- To maintain master's with respect to Specifications, SAP material codes.
- To prepare finished product Specifications for commercial products with respect to any queries from Clients.
- For New Product launch support to BD & Regulatory Team.
- To prepare Risk Assessment Reports as per new Guidelines to fulfill requirements of existing & new Market.
- To review and approve of Dossier for New Products & renewal Products.
- Review and approve - Specification and Method of Analysis in LIMS
Experience : 10yrs
Location : Thane
Qualification : Pharma/Science Graduate
