Quality Assurance Pharmacist

About the position

Quality Assurance Pharmacist
Location: Permanent - Onsite - Cape Town, South Africa
Essential Requirements: Pharmacist degree and 2 years QA audit and quality compliance experience in the pharmaceutical manufacturing industry

Our client, a leading pharmaceutical company specializing in production, packaging, and warehousing, is also renowned for its third-party contracting services to well-known pharmaceutical companies. They are seeking a dedicated and experienced Quality Assurance Pharmacist to join their dynamic team.

Responsibility Summary:
The Quality Assurance Pharmacist will oversee all key elements of the Quality Management System and ensure its effectiveness in compliance. Responsible for audits and continuously ensuring audit readiness in line with regularity adherence. The role ensures quality standards and current procedures meet GxP regulations. The QA Pharmacist coordinates and liaises with other departments to foster a robust Quality Assurance culture throughout the company, continuously improving quality standards and providing guidance as required.

Qualification and Experience Required, but not limited to:

• B Pharm degree and registered with SAPC - non negotiable
• English and Afrikaans (Basic)
• Knowledge/experience of ISO 13485 - advantageous but not required
• Understanding of the Regulatory Framework for Medical Devices in South Africa and/or the EU Market
• Minimum of 2 to 5 years QA experience in the Pharmaceutical Manufacturing Industry, demonstrate experience in conducting audits and ensuring compliance adherence
• Experience in SOP and master document compilation/control
• Thorough understanding of the Pharmaceutical Regulatory environment

Quality Assurance:

• Review, revise, update, and authorize all departmental SOPs
• Manage QA departmental functions, including document control, Site Master File, Quality Manual, and Quality Policy
• Implement the Validation Master Plan and oversee internal and external audits
• Handle non-conformance documentation and investigations, adverse drug reaction support, root cause analysis, corrective and preventative actions, change controls, process validations, and product quality reviews
• Ensure adequate pest control and approve specification sheets for release
• Establish and maintain Technical Quality Agreements with third-party contractors
• Manage regulatory licenses and liaise with regulatory bodies
• Ensure all product quality complaints are identified, investigated, and resolved correctly
• Ensure batch traceability for recalls and that all invoices carry batch numbers
• Handle rejected goods in a procedurally correct manner

GMP / GWP / GHP:

• Conduct inspection audits to ensure manufacturing operations meet approved GMP procedures and product quality is maintained during storage and transport
• Oversee adequate packaging facilities and adherence to written systems until the final product is ready for distribution
• Ensure the completion of logs by the distribution/warehousing facility and maintain an adequate pest control program
• Perform self-inspection and internal audits and manage deviations
• Maintain effective vendor management and update the Approved Vendor List
• Quarantine, sample, and release batches for manufacturing and distribution
• Ensure Good Manufacturing Practice training is provided to all employees and maintain Schedule 5 & 6 register

Additional Information:

• This position has 2 direct reports: QA/QC Assistants
• The QA Pharmacist will report to the Responsible Pharmacist
• Minimal travel for local audits in Cape Town
• Medical Devices experience or knowledge is advantageous but not required
• From time to time the role will require working longer hours and occasional Saturday work depending on the operational needs to meet deadlines
• If you meet the above criteria and are passionate about quality assurance in the pharmaceutical industry, we would love to hear from you. Apply now to join a company committed to excellence in healthcare.

Application Instructions:
Please send your detailed CV showcasing the extent of suitable QA experience to

[Email Address Removed]

Additional supporting application information required with CV submit: Forward copies of Qualifications listed on CV including Matric certificate, SAPC Registration and ID.

Desired Skills:

• B. Pharm degree and registered with SAPC - non negotiable

Desired Work Experience:

• 2 to 5 years

Desired Qualification Level & Accreditations:

• Degree
• South African Pharmacy Council