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Qc Lead Micro

3 months 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 QC Lead Micro & Biological Testing to join a goal-oriented team.

QUALIFICATIONS NEEDED:

  • Degree or diploma in Microbiology / Biochemistry/Biotechnology or equivalent.

NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE:

  • At least 5 years of experience in the sterile vaccine/pharmaceutical/biotech manufacturing industry
  • At least 23 years of experience at the supervisory level.
  • Experience in quality and regulatory compliance within a cGMP facility.
  • Technical knowledge of aseptic practices and Microbiological/Biological methods.
  • Strong knowledge of sterile manufacturing environment
  • Experience in having faced successful local and/or international quality audits.

KEY DUTIES & RESPONSIBILITIES OF THE ROLE:

  • Drive continuous improvement plans and priorities through the implementation of appropriate tools or methodologies to proactively manage risk, reduce wastage, and improve quality on site.
  • Manage approval of laboratory raw data and investigation of outofspecification results where applicable (Micro & Biological).
  • Manage the compilation of analytical method validation/ verification protocols and reports.
  • Manage the compilation review, approval of user requirement specification and/or user briefs, qualification documents, CAPEX approval, Risk Assessment, Change Management, and implementation of new and updated equipment and software.
  • Manage the selection and procurement of analytical test equipment and participation in equipment qualification, (Micro & Biological).
  • Manage the execution of project activities according to agreed project timelines.
  • Manage Sampling and testing and release of starting materials (e.g., raw materials, production devices, and packaging materials) used in production processes.
  • Manage Micro & Biological testing of intermediate and finished product testing as per product specifications.
  • Manage visual inspection activities of inprocess and final products as per the required SOPs and product specifications related to vaccines and packaging activities.
  • Manage the review of analytical method validation/ verification protocols and reports and coordination with a focus on Micro & Biological testing.
  • Maintaining that Stability Program, including compiling stability protocols and reports, related to Micro & Biological testing.
  • Participation in project teams as a QC representative.
  • Ensure that Micro & Biological testing is performed according to the Biovac Stability Program. Assist with the compilation of stability protocols and reports.
  • Manage the transfer of analytical methods from technology transfer partners to Biovac and their implementation in the laboratory, with a focus on Micro & Biological testing.
  • Manage the writing and updating of material and product test methods and standard operating procedures.
  • Manage Data Integrity in the QC Laboratory with reference to Micro & Biological along with new and upcoming technologies (e.g., LIMS, new hardware and software programs, new technologies), when available.
  • Liaise with suppliers on technical issues where applicable.
  • Manage training, coaching, and competency assessment of Micro & Biological staff to approve procedures and protocols.
  • Participate in quality audits and close any gaps in findings.
  • Ensure that OOS and OOT investigations are initiated and completed to the correct standard within the required due dates.
  • Participate in inspections, investigations, risk management, and quality review exercises.
  • Execute project activities according to agreed project timelines and within cGMP requirements.
  • Manage the Operational Expense (OPEX), Capital expenditure (CAPEX), cost control, and budgeting for the Micro & Biological department in conjunction with the QC Manager.
  • Participate in significant Micro & Biological investigations that can impact product Quality and patient safety.
  • Lead significant Micro & Biological Risk assessments in accordance with cGMP guidelines (e.g., ICH Q9, ICH Q10, etc).
  • Lead engagement with external thirdparty stakeholders (e.g., Pfizer and Sanofi) regarding Micro & Biological areas.
  • Provide technical guidance to QC teams and to other stakeholders within the business from a Micro & Biological perspective.
  • Manage the review and approval of significant documentation within the Micro & Biological team as defined within local procedures.
  • Manage the Environmental monitoring program, for the site and ensure that it meets cGMP requirements.
  • Manage Environmental Monitoring data analysis and reports are provided to stakeholders.
  • Provide specialist support for GMP cell banks and work with Science & Innovation (S&I) team to transfer cell bank knowledge into the Microbiology/Biochemistry department.
  • Review and approve significant documentation w