Release Pharmacist

2 weeks ago

Cape Town, Western Cape, South Africa Biovac Full time

BIOVAC is one of the leading sterile vaccine manufacturers rooted in Africa, with our core purpose being to "protect life".

We are looking to hire a dynamic, passionate, confident, proactive, and meticulous Release Pharmacist to join a goal-oriented team.

QUALIFICATIONS NEEDED:

  • Bachelor's degree in pharmacy or Diploma in Pharmacy.

NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE:

  • At least 12 years experience in batch release for sterile manufacturing.
  • Experience in quality and regulatory compliance within a cGMP facility.
  • Experience in aseptic (sterile) manufacturing
  • Technical report/process writing skills.
  • Excellent communication skills and operational planning.
  • Experience in having faced successfully local and/ or international quality audits.

KEY DUTIES & RESPONSIBILITIES OF THE ROLE:

  • Review and approve all manufacturing batch records for all various production departments within the defined timelines.
  • Review and approval of QC documents required to adhere to guidelines for batch release within the defined timelines.
  • Approval and final release of manufacturing products to the market and/or third party as applicable within the defined timelines.
  • Responsible for the release of products; and those products are released in accordance with appropriate marketing authorization following full batch and testing record review.
  • Evaluate and authorize reprocessing of products or materials.
  • Ensure that products are released in accordance with appropriate marketing authorization following full batch and testing record review.
  • Assist Release Manager and Head of Pharmaceutical Services/RP and participate in investigations in the event of medicine recalls and compile relevant reports.
  • Adhere to Quality Standards to comply with SAHPRA and PIC/S guidelines with regards to for e.g., Batch documentation auditing and control, Finished product release, Quality of products out in the market.
  • Responsible for the handling scheduled substances in a pharmacy. Legal requirements regarding the documentation and control of scheduled medicines should be adhered to.
  • Responsible for handling product quality complaints.
  • Respond and manage quality reviews to adverse drug reactions postimmunization and participate in investigations with the pharmacovigilance officer.
  • Responsible for the compilation and review of Annual Product Quality Reviews.
  • Assist the Release manager to ensure that Annual reports are completed for the department where required.
  • Communicate any delays in advance in terms of Batch release not adhering to specified timelines.
  • Provide support and be available to the production departments.
  • Ensuring that the department is audit ready by closing out audit findings timeously.
  • Ensure Deviations, Change Controls, and CAPAs are handled effectively.
  • Assist the Release Manager in the management of the process of Advertising medicines.
  • Data development, trending & reporting.
**Application Deadline: 05 April 2023

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