Quality Assurance Specialist

Micro Crispr Pvt. Ltd.; Vapi; On-site; INR 800,000 - 1,400,000; Full time

Job summary

Micro Crispr Pvt. Ltd. in Vapi seeks a Senior Executive / Assistant Manager for Quality Assurance focusing on the Document Management System. The role emphasizes cGMP compliant documentation, GDP and data integrity, and collaboration with QA teams.

You will own SOP maintenance, master indices, and document lifecycle control while supporting audits and CAPA implementations in a regulated pharma setting.

Qualifications

• 5-7 years of QA experience with hands-on DMS in regulated pharma manufacturing.
• Experience in cGMP, GDP, and data integrity practices.
• Familiarity with document lifecycle, archival, and revision control.

Responsibilities

• Prepare, review, and update QA SOPs, formats, templates and QA documents to ensure regulatory compliance.
• Maintain controlled cGMP documentation for DMS, GDP and document control processes.
• Develop annual training plans and conduct induction and refresher trainings on GDP and data integrity.
• Maintain master index of all controlled documents (SOPs, EOPs, WIs, specs, protocols, reports).
• Monitor document review schedules and ensure timely revisions and archival.
• Support internal audits and regulatory inspections with controlled documents and traceability.

Education

B.Pharm

M.Pharm

M.Sc. (Pharmaceutical Sciences or Life Sciences)

Job description

Senior Executive / Assistant Manager - Quality Assurance (Document Management System)

Department - Quality Assurance (QA)

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 environment.

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.
• Assign and maintain unique numbering systems for batch numbers, project codes, equipment IDs, document numbers, change controls, URS, impact assessments, SOPs, EOPs, STPs, WIs, specifications, protocols, validation documents, qualification documents, reports, and other controlled records.
• Monitor document periodic review schedules and ensure timely revision of documents before their due dates.
• Maintain document retention schedules and archive records in accordance with company procedures, regulatory requirements, and record retention policies.
• Ensure compliance with Good Documentation Practices (GDP), ALCOA+ principles, data integrity requirements, and applicable cGMP regulations during document creation, review, issuance, and archival.
• Support internal audits, and regulatory inspections by providing controlled documents, document history, issuance records, archival records, and document traceability as required.
• Investigate document related deviations, documentation errors, missing records, and non-conformances, and participate in the implementation of appropriate CAPAs.
• Generate and maintain document control metrics, including document review status, overdue revisions, issuance records, archival status, and document compliance trends for periodic management review.
• Implement, validate, and administer electronic Document Management Systems (eDMS) for document request, review, approval, issuance, version control, retrieval, archival, electronic signatures, and document lifecycle management in compliance with regulatory guidelines and applicable data integrity requirements.