Regulatory Affairs Pharmacist
3 weeks ago
Estimated Salary: $70,000 - $100,000 per year
About the RoleWe are seeking a highly skilled Regulatory Affairs Pharmacist to join our team at O'Brien Recruitment. As a Regulatory Affairs Pharmacist, you will be responsible for ensuring compliance with regulatory requirements and industry standards.
Key Responsibilities:
- Maintain alignment with established Quality Management Systems (QMS) and Good Manufacturing Practices (GMP)
- Conduct regular audits and assessments to identify areas for improvement
- Develop and implement corrective actions to address deviations and non-conformities
- Collaborate with cross-functional teams to ensure compliance with regulatory requirements
- Manage the Change Control process and escalate issues to the QA Manager when needed
- Chair Change Control meetings
- Ensure all products are appropriately controlled, proper procedures are followed, and batch releases are conducted
- Minimum of 3 years' experience in a regulatory affairs role
- Strong background in production and quality assurance
- In-depth knowledge of PICS, SAHPRA, ISO 9001, and ISO 22716 requirements
- Attention to detail, strong communication skills, and good presentation abilities at all organizational levels
- Proficiency in MS Office
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