Senior Responsible Pharmacist - Regulatory & GMP Oversight

Ultra Personnel

Midrand

On-site

ZAR 950,000 - 1,250,000

Full time

4 days ago
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Job summary

Ultra Personnel in Midrand seeks a Responsible Pharmacist to ensure compliance with the Pharmacy Act, Medicines and Related Substances Act, SAPC and SAHPRA requirements, and GMP/GPP standards. The RP will oversee licensed activities, medicines control, and product release with escalation of governance concerns.

The role requires supervision of pharmacists and personnel, robust QA oversight, and effective regulatory engagement across inspections and reporting, supporting a compliant

Qualifications

  • Bachelor of Pharmacy degree required.
  • Registered pharmacist with SAPC in good standing.
  • 5+ years post-community service in sterile manufacturing.
  • In-depth knowledge of PIC/S GMP Annex 1.
  • Experience with non-sterile pharmaceuticals.
  • In-depth knowledge of PIC/S GMP Annex 9.

Responsibilities

  • Ensure compliance with Pharmacy Act and SAPC requirements.
  • Oversee license compliance and facility governance.
  • Manage Medicines and Scheduled Substances control.
  • Review batch disposition, product release and rejections.
  • Supervise pharmaceutical staff and delegation.
  • Oversee Pharmaceutical Quality System (CAPAs, deviations, change control).
  • Ensure product quality, patient safety and regulatory compliance.
  • Engage regulatory authorities (SAPC, SAHPRA) and inspections.
  • Manage complaints, recalls and regulatory reporting.
  • Oversee GMP, data integrity and risk oversight.
  • Lead governance, training and compliance culture.
  • Collaborate with QA, QA, Regulatory Affairs, Supply Chain.

Skills

Regulatory Compliance
GMP/GPP Knowledge
Quality Assurance
Pharmacist Supervision

Education

B Pharm Degree
Registered Practicing Pharmacist (SAPC)
PIC/S Annex 1 Knowledge
PIC/S Annex 9 Knowledge

Job description

Ultra Personnel in Midrand seeks a Responsible Pharmacist to ensure compliance with the Pharmacy Act, Medicines and Related Substances Act, SAPC and SAHPRA requirements, and GMP/GPP standards. The RP will oversee licensed activities, medicines control, and product release with escalation of governance concerns.

The role requires supervision of pharmacists and personnel, robust QA oversight, and effective regulatory engagement across inspections and reporting, supporting a compliant

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