drjobs QC Lead Chemistry & Material Handling

QC Lead Chemistry & Material Handling

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1 Vacancy
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Job Location drjobs

Cape Town - South Africa

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

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 QC Lead: Chemistry & Material Handling to join a goal-oriented team.

QUALIFICATIONS NEEDED:

  • Degree or diploma in Chemistry / Analytical Chemistry / Biochemistry or equivalent.
  • Recognition is given to Prior Learning and practical experience.

NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE:

  • At least 6 years experience in vaccine / pharmaceutical / biotech manufacturing industry.
  • At least 3 years experience at management level.
  • Experience in quality and regulatory compliance within a cGMP facility.
  • Strong leadership and team management abilities.
  • Experience with LIMS chromatography data systems and /or electronic documentation systems.
  • Proficient in method and data review.
  • Proven troubleshooting and problem-solving abilities within analytical testing.

KEY DUTIES & RESPONSIBILITIES OF THE ROLE:

  • Drive continuous improvement plans and priorities through the implementations of appropriate tools or methodologies to proactively manage risk reduce wastage and to improve quality on site.
  • Management of all Materials (Raw Material and Packaging) testing and Chemistry testing activities for product release.
  • Participation in project teams as QC representative.
  • Assist with the transfer of analytical methods from technology transfer partners to Biovac and their implementation in the laboratory.
  • Assist with compiling of analytical method validation / verification protocols and reports.
  • Assist with selection of analytical test equipment and participation in equipment qualification e.g. review of qualification documents.
  • Assist with writing and updating of material and product specifications and test methods and standard operating procedures.
  • Liaison with suppliers on technical issues where applicable.
  • Maintaining laboratory operations at cGMP standards to ensure quality safety and regulatory compliance.
  • Departmental Management of the QC laboratory budget ensuring alignment with GMP and regulatory requirements.
  • Forecast costs for analytical testing stability studies reference standards and consumables.
  • Control expenditure related to equipment calibration maintenance and outsourced testing.
  • Collaborate with procurement to optimize vendor contracts for reagents instruments and lab services.
  • Prepare CAPEX proposals for new analytical technologies and lab upgrades.
  • Monitor budget performance analyze variances and implement corrective actions.
  • Maintaining that Stability Program including compiling stability protocols and reports.
  • Ensure that relevant testing is performed according to the Biovac Stability Program.
  • Assist with the compilation of stability protocols and reports.
  • Participation in quality audits and closing any gaps of findings.
  • Ensure that OOS and OOT investigations are initiated and completed to the correct standard.
  • Identify and / or participate in inspections investigations risk management and quality review exercises.
  • Chemistry testing to support aseptic vaccine manufacturing performed to required quality and regulatory standards and within agreed time frames.
  • Chemistry assay qualifications validations and verifications.
  • Undisrupted punctual and safe operation of staff and processes pertaining to Chemistry Testing and the institutes operations.
  • Technology transfer activities involving Chemistry testing within the agreed time frames.
  • Review specifications test methods and other QC procedures.
  • Ensure the qualification and maintenance of premises and equipment used by the Chemistry team.
  • Ensure that the required initial and continuing training of his teams personnel is carried out and adapted according to need.
  • Responsible to ensure that the Material Handling (Raw Material and Packaging Materials) sections deliver services and solutions in alignment with pharmaceutical quality system requirements.
  • Approve or reject starting materials packaging materials intermediate bulk and finished product.
  • Co-ordinate sampling and testing of sampling materials packaging materials components production devices intermediate bulk and finished products as week as all warehouse related activities.

Application Deadline: 14 October 2025

If you do not receive a response from us within three weeks of submitting your application please understand that your application was not successful.

Disclaimer:

Dear Applicant we appreciate your interest in joining our organization. It is imperative for us that you understand how we handle your information. We are committed to ensuring the security and confidentiality of the information you provide. Your personal details will be collected for the sole purpose of the application process and will be used strictly for that purpose. By applying you acknowledge and consent to the collection use and protection of your personal information in accordance with our privacy policy. If you have any inquiries or concerns our Human Capital department is available to provide clarification. We look forward to reviewing your application.

Employment Type

Full Time

Company Industry

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