Director of Regulatory Compliance
1 day ago
Our commitment to quality is built on a foundation of customer satisfaction, continuous improvement, and excellence in everything we do.
We're seeking an experienced professional to join our team as Head of Pharmaceutical Quality. In this role, you'll be responsible for ensuring all products and processes comply with relevant regulations and guidelines.
Key Responsibilities:
Develop, implement, and maintain the Quality Management System (QMS) in compliance with GMP, regulatory requirements, and company policies.
- Oversee the management of SOPs, Work Instructions, and other quality-related documentation.
- Collaborate with the Qualified Person (QP) to ensure batch documentation is reviewed, and products are released in compliance with regulatory requirements and company standards.
Audits and Inspections:
- Lead internal audits and participate in external audits and regulatory inspections.
- Prepare audit reports, manage corrective and preventive actions (CAPAs), and follow up on audit findings.
Training and Development:
- Develop and execute training programs for staff on quality-related topics to ensure compliance with regulatory requirements and company standards.
- Monitor the effectiveness of training programs and maintain training records.
Required Qualifications:
- Bachelor's degree or higher in Pharmacy, Chemistry, Biology, or a related field.
- A minimum of 5 years of experience in quality management within the pharmaceutical industry.
- In-depth knowledge of GMP, FDA, EMA, and other relevant regulatory requirements.
- Experience with QMS implementation and management.
Benefits:
- A competitive salary and benefits package.
- Ongoing training and development opportunities.
- The chance to work with a talented and diverse team.
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