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Senior Quality Assurance Specialist
2 weeks ago
Key Responsibilities:
Develop and implement quality assurance strategies to ensure compliance with regulatory standards.
Planning & Execution:
- Coordinate audits for suppliers, contract laboratories, and service providers to ensure compliance with internal policies and regulatory requirements.
- Conduct root cause investigations into quality issues and significant events.
- Identify and report quality and compliance risks and gaps.
- Review audit responses, track corrective actions, and ensure timely closure of audit findings.
Documentation & Record Keeping:
- Support the preparation and publication of approved supplier lists.
- Maintain accurate and up-to-date records in the audit management system.
Qualifications:
- Minimum 10-15 years of experience in quality assurance or quality control.
- Strong knowledge of GMP regulations, quality systems, and auditing practices.
- Ability to evaluate manufacturing facilities and identify areas for improvement.
Skills:
- Excellent communication and interpersonal skills.
- Critical thinking and analytical abilities.
- Conflict resolution and stakeholder collaboration.
