Quality Assurance Specialist
6 days ago
This Compliance Associate role involves ensuring all quality aspects of the organization are met.
Key Responsibilities:- Manage all quality facets, including deviation, change control, complaint, internal audits, regulatory inspections, and quality alerts.
- Monitor and evaluate compliance with cGMP regulations through Key Performance Indicators (KPIs).
- Ensure departments conduct self-inspections within defined timelines.
- Support audit readiness for internal and external assessments.
- Closure of change control, deviation, CAPAs, and complaints in a timely manner.
- Investigate product quality issues and escalate critical concerns to QA compliance lead.
- Oversee management review and ensure adherence to HQS, regulatory, and statutory requirements.
- Lead investigations into deviations and ensure closure within established timelines.
- Track corrective and preventive actions (CAPAs) and implement timely escalation of issues.
- Participate in internal, regulatory, and corporate audits.
- Pharm-D or M.Sc in Chemistry/Microbiology.
- 0-3 years of experience in QA or production.
- Regulatory knowledge.
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