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Intas
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Manufacturing (Injectable) QMS - Assistant Manager

Manufacturing (Injectable) QMS - Assistant Manager

Intas

7 - 11 years

7 - 14 Lacs

ahmedabad

Posted:1 day ago| Platform:

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Skills Required

oos qms injectables deviation qms implementation change control market complaints oot sterile injection

Work Mode

Work from Office

Job Type

Full Time

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.

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