Assistant Manager, QMS
2 days ago
Job Description
- Review and approve change control requests raised by cross-functional teams.
- Assess GMP, regulatory, and quality impact for process, equipment, documents, and systems.
- Perform/verify risk assessments and ensure adequate mitigation.
- Review and approve revised documents (SOPs, BMR/BPR, validation protocols/reports).
- Ensure validation/qualification requirements are identified and completed.
- Verify training, implementation readiness, and completeness of supporting data.
- Approve and close change controls within defined QMS timelines.
- Ensure compliance with cGMP, data integrity, and regulatory guidelines.
Skills Required
Analytical & problem-solving skills : Advanced
cGMP, GDP & ICH Q10 knowledge : Advanced
Global regulatory compliance knowledge : Advanced
Automated QMS platform proficiency : Advanced
Data integrity (ALCOA+) knowledge : Advanced
QualificationsM - Pharmacy
B- Pharmacy
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