- Quality Assurance Compliance
- Ensure compliance with cGMP, GLP, and regulatory requirements (WHO, USFDA, MHRA, etc.)
- Handle audits (internal, external, regulatory) and ensure audit readiness at all times
- Review and approve SOPs, BMRs, BPRs, protocols, and reports
- Documentation Management
- Oversee preparation, review, and control of quality documents
- Ensure proper documentation practices (GDP) across departments
- Manage change control, deviation, CAPA, and risk assessment systems
- In-Process Quality Assurance (IPQA)
- Supervise IPQA activities during manufacturing and packing processes
- Ensure line clearance, in-process checks, and sampling activities are properly executed
- Monitor critical process parameters and ensure compliance
- Team Management
- Lead and mentor QA/IPQA team members
- Allocate responsibilities and ensure effective workflow
- Conduct training programs on GMP and quality systems
- Validation Qualification
- Support process validation, cleaning validation, and equipment qualification
- Review validation protocols and reports
- Batch Release
- Review batch manufacturing and packing records
- Ensure timely batch disposition and release
- Continuous Improvement
- Identify gaps and implement quality improvement initiatives
- Drive a culture of quality and compliance within the organization
Required Skills
- Leads and motivates the team effectively.
- Communicates clearly and professionally.
- Ensures accuracy with strong attention to detail.
- Solves problems efficiently.
- Manages time and priorities well.
- Collaborates with teams smoothly.
- Adapts quickly to changes.