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Regulatory QA(Responsible Pharmacist)

5 months ago

Johannesburg, South Africa Adzuna ZA B C2 Full time

Minimum Requirements:

  • Must have Matric / Grade 12
  • B. Pharm degree.
  • Registered with the South African Pharmacy council.
  • At least 2-3 years regulatory experience.
  • Experience in compilation and submission of Act 101 (SAHPRA) Dossiers.
  • Thorough understanding of GMP.
  • Must be computer literate (MS Word, Excel and PowerPoint, intermediate to advanced skills required).
  • High accuracy and attention to detail skills.
  • Strong work ethic.

The following would enhance your position and will be an advantage:

  • Previous Quality Assurance Management experience.
  • Experience as a Responsible Pharmacist in a Manufacturing environment.
  • Experience in compilation and submission of Act. 36 Dossiers.
  • Animal Health industry experience.
  • Knowledge of regulatory submissions in Zimbabwe, Namibia & Zambia.
  • Pharmaceutical Production knowledge.
  • CTD submission experience will be an advantage

Main Accountabilities:

  • Act as Responsible Pharmacist for the entity
  • Regulatory Strategy & intelligence.
  • Responsible for the Regulatory Plan and the successful execution thereof.
  • Dossier preparation, compliance checks & submissions.
  • LOQ Answer, submission & interaction with authorities.
  • Maintenance & product life cycle management.
  • Knowledge and intelligence management.
  • Right level of quality & strategy.
  • Quality Management System& strategy.
  • Community building and activation.
  • Responsible for Pharmacovigilance.
  • Audits & inspections.
  • Product release.
  • CAPA identification and implementation.
  • Deviation and non-conformance management.
  • Annual Product quality review management.
  • Legal Compliance with Act. 101 & Act. 53