Regulatory Compliance Specialist
2 weeks ago
O'Brien Recruitment is seeking a highly skilled Regulatory Compliance Specialist to join our client's team in the pharmaceutical industry. This role will be responsible for ensuring compliance with quality assurance requirements, maintaining alignment with established quality management systems (QMS), and adhering to Good Manufacturing Practices (GMP) and legal standards.
Key Responsibilities- Maintain compliance with ISO 9001 and ISO 22716 across all areas of the organization.
- Conduct root cause investigations and implement corrective actions to prevent recurrence.
- Facilitate effective non-conformance meetings to ensure actions are completed.
- Ensure annual QMS reviews are conducted per ISO standards.
- Conduct internal and supplier audits and hold follow-up meetings with relevant managers or suppliers to address findings.
- Oversee all aspects of the customer complaints process.
- Manage the distributor satisfaction survey process.
- Handle 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 (e.g., supplements).
- Hold monthly hygiene feedback meetings with managers to follow up on findings and address deviations.
- Ensure the organization complies with cosmetic and pharmaceutical cGMP.
- Provide relevant monthly or quarterly reports to the Quality Assurance Manager.
- Minimum of 2 years' experience as a Quality Assurance Pharmacist in a manufacturing environment.
- 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.
- Bachelor of Pharmacy.
- Registered with the South Africa Pharmacy Council.
This role offers a competitive salary between R600,000 - R800,000 per annum, depending on experience, plus benefits.
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