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Sami Sabinsa Group
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Assistant Manager -QA(Hassan)

Assistant Manager -QA(Hassan)

Sami Sabinsa Group

10 - 19 years

7 - 10 Lacs

hassan

Posted:3 weeks ago| Platform:

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Skills Required

quality assurance

Work Mode

Work from Office

Job Type

Full Time

Job Description

1. Quality Management System (QMS) Oversight

Lead and manage QMS processes including Deviations, CAPA, Change Controls, Incident Management, and Risk Assessments.
Ensure timely closure of QMS records and investigation reports.
Conduct Root Cause Analysis (RCA) using tools like 5-Why, Fishbone, CAPA effectiveness checks, etc.

2. Documentation & Document Control

Review and approve SOPs, BMRs, BPRs, specifications, and master documents.
Ensure controlled documentation as per Data Integrity and ALCOA+ principles.
Maintain electronic and manual document systems as per SOP.

3. Audit Management

Prepare and support internal, external, customer, and regulatory audits (WHO, USFDA, MHRA, EU, etc.).
Track audit observations and ensure timely implementation of corrective and preventive actions.
Conduct internal GMP audits and vendor audits as needed.

4. Compliance & GMP Monitoring

Monitor adherence to cGMP across production, warehouse, QC, and engineering areas.
Ensure timely review of shop floor quality issues and provide QA guidance.
Maintain compliance with regulatory guidelines and corporate quality policies.

5. Training & Quality Culture Development

Plan and conduct GMP, SOP, Data Integrity, and QMS training sessions.
Strengthen quality culture across all levels through periodic awareness programs.
Maintain training records and evaluate training effectiveness.

6. Change & Risk Management

Evaluate and assess impact of proposed changes in materials, equipment, processes, and documents.
Conduct risk assessment (FMEA, hazard analysis) for process improvements and changes

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