Regulatory Quality Assurance Specialist
4 weeks ago
ES Recruitment is seeking a highly skilled Regulatory QA (Responsible Pharmacist) to join our client's team in the pharmaceutical industry.
Key Responsibilities:- Act as Responsible Pharmacist for the entity, ensuring compliance with regulatory requirements.
- Develop and implement regulatory strategies and intelligence to drive business growth.
- Prepare and submit regulatory dossiers, ensuring accuracy and attention to detail.
- Manage and maintain knowledge and intelligence on regulatory submissions, including Act 101 and Act 53.
- Collaborate with cross-functional teams to ensure quality and compliance.
- Identify and implement corrective actions to address deviations and non-conformances.
- Develop and maintain a quality management system, ensuring alignment with regulatory requirements.
- B. Pharm degree and registration with the South African Pharmacy Council.
- At least 2-3 years of regulatory experience, with a focus on pharmaceuticals.
- Strong understanding of GMP and regulatory submissions, including Act 101 and Act 53.
- Excellent communication and interpersonal skills, with the ability to work effectively in a team environment.
- Highly organized and detail-oriented, with the ability to prioritize tasks and manage multiple projects simultaneously.
- Previous experience as a Quality Assurance Manager or Regulatory Affairs Specialist.
- Knowledge of regulatory submissions in Zimbabwe, Namibia, and Zambia.
- Experience in pharmaceutical production and animal health industries.
- CTD submission experience and knowledge of quality management systems.
If you are a motivated and experienced Regulatory QA (Responsible Pharmacist) looking for a new challenge, please submit your application, including your resume and a cover letter, to ES Recruitment.
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