Senior Executive / Assistant Manager – Quality Assurance (Document Management System)
Department - Quality Assurance (QA)
Location - Vapi, Gujarat

Qualification
B.Pharm / M.Pharm / M.Sc. (Pharmaceutical Sciences or Life Sciences)
Candidates from the pharmaceutical industry will be preferred.

Experience
5–7 years of relevant experience in Quality Assurance with hands-on experience in Document Management Systems (DMS) within a regulated pharmaceutical manufacturing workplace.

Key Responsibilities

Prepare, review, revise, and periodically update QA SOPs, formats, templates, and related quality documents to ensure compliance with internal quality systems, cGMP requirements, and applicable regulatory guidelines.
Prepare, review, and maintain controlled cGMP documentation related to the document management system (DMS), Good Documentation Practices (GDP), document control, and other quality system processes as required.
Develop annual training plans, coordinate training schedules,



and conduct induction and refresher training programs for employees on good documentation practices, data integrity, and document control procedures.
Prepare, maintain, and periodically update the master index of all controlled documents, including SOPs, EOPs, STPs, Work Instructions (WIs), specifications, protocols, reports, forms, templates, and other quality documents.
Manage the complete document lifecycle, including document creation, review, approval, issuance, revision, retrieval, distribution, reconciliation, retention, archival, and controlled destruction in accordance with established procedures.
Control the issuance and distribution of master copies, controlled copies, uncontrolled copies, obsolete documents, and effective versions.
Issue, reconcile, retrieve, and maintain controlled records such as laboratory notebooks, logbooks, batch manufacturing records (BMRs), analytical test records (ATRs), batch labels, and other controlled formats in accordance with internal procedures.

📌 Quality Assurance Specialist (Vapi)
🏢 Micro Crispr
📍 Vapi