
Lead Compliance Specialist
2 days ago
Job Title: Lead Compliance Specialist
Job Description:
We are seeking a skilled and experienced professional to lead our compliance efforts. As Lead Compliance Specialist, you will develop and implement quality audit procedures, maintain GMP quality systems, and ensure compliance with regulatory requirements.
Key Responsibilities:
- Develop and maintain a robust Quality Management System (QMS) that ensures quality standards are recognized and maintained across the organization.
- Coordinate and finalize Qualified Person audits and Regulatory Inspections.
- Oversight of investigations of all non-conformances (deviations, complaints, etc.).
- Ensure all validation activities are carried out according to approved protocols and requirements.
- Maintain and improve departmental operational performance to meet regulatory requirements and company Standard Operating Procedures (SOPs).
- Review, approve, and issue Batch Manufacturing Record / Batch Packaging Record.
Requirements:
- Experience in quality assurance and regulatory compliance.
- Knowledge of GMP, EU GMP/PICS/TG/MHRA, and other relevant regulations.
- Strong analytical and problem-solving skills.
- Ability to work independently and as part of a team.
- Effective communication and leadership skills.
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