Manufacturing (Injectable) QMS - Assistant Manager
- Intas
- 7 - 11 years
- Ahmedabad
- 5 months ago
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Job Description
Key Responsibilities:
1. Documentation & Compliance
- Ensure compliance with cGMP, WHO, EU GMP, USFDA, and other regulatory requirements specific to injectable formulations.
- Review, control, and maintain SOPs, Quality Manuals, and other QMS documents.
- Control issuance, retrieval, and archival of GMP documents as per SOPs.
2. Deviations & CAPA
- Investigation and documentation of deviations, incidents, and non-conformances.
- Identify root causes using tools like 5 Whys / Fishbone analysis.
- Initiate, track, and ensure timely closure of Corrective and Preventive Actions (CAPA).
3. Change Control
- Review and manage Change Control records related to injectable manufacturing.
- Ensure impact assessments are performed for facility, equipment, process, and document changes.
4. Risk Management
- Participate in risk assessments (FMEA, HACCP, etc.) for aseptic processes, sterilization, and contamination controls.
5. Training & Compliance Monitoring
- Coordinate and document GMP and QMS training for all departments.
- Ensure QMS compliance through routine internal audits and walk-through inspections.
6. Quality Metrics & Reporting
- Maintain QMS performance indicators (Deviations, CAPAs, Change Controls, Complaints, etc.)
- Prepare monthly QMS reports and present during Quality Review Meetings.
7. Audit & Regulatory Support
- Support during internal/external audits (USFDA, MHRA, WHO, etc.)
- Ensure timely responses to audit observations and follow-up actions.
Key Skills & Knowledge:
- In-depth understanding of QMS systems in sterile/injectable manufacturing.
- Sound knowledge of regulatory guidelines (21 CFR Part 210/211, EU GMP Annex 1, etc.)
- Strong communication and documentation skills.
- Hands-on experience with QMS software (e.g., TrackWise, MasterControl) is a plus.
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: Quality AssuranceRole Category: Production & ManufacturingRole: Production & Manufacturing - OtherEmployement Type: Full timeContact Details:
Company: IntasLocation(s): Ahmedabad+ View Contact
Keyskills: OOS QMS Injectables Deviation QMS Implementation Change Control Market Complaints OOT Sterile Injection
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