Qc Supervisor Micro - Cape Town, South Africa - Biovac

Biovac
Biovac
Verified Company
Cape Town, South Africa

2 weeks ago

Thabo Mthembu

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Thabo Mthembu

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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 Supervisor Micro & Environmental Monitoring to join a goal-oriented team.


QUALIFICATIONS NEEDED:


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

NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE:


  • At least 3 years of experience in the vaccine/pharmaceutical/biotech manufacturing industry with QC Laboratory,
  • At least 1year experience at a supervisor level.
  • Experience in quality and regulatory compliance within a cGMP facility.
  • Experience in aseptic (sterile) manufacturing
  • Experience in having faced successful local and/or international quality audits (i.e., SAHPRA and WHO).

KEY DUTIES & RESPONSIBILITIES OF THE ROLE:

  • Driving continuous improvement plans and priorities through the implementation of appropriate tools or methodologies to proactively manage risk, reduce wastage, and improve quality on-site.
  • Coordinating all the testing and activities associated to ensure that the Environmental Monitoring Program is executed as per procedures for starting materials intermediate, bulk, and final products.
  • Executing the Environmental Monitoring (EM) Program for assessing the manufacturing environment and utilities and escalating associated issues.
  • Testing of Sterility samples, Stability testing, and analytical verification and/or analytical validation samples related to Microbiology testing & Environmental Monitoring.
  • Identifying organisms related to Microbiology testing & Environmental Monitoring, and supporting the associated investigation, when necessary.
  • Inspecting of Aseptic Process Simulations (APS) samples and associated activities.
  • Compiling data trends, data analysis, and associated reports for the EM program to the correct standard and on time.
  • Reviewing of laboratory raw data, including OOS/MDDs and or OOT results from internal and/or external testing related to Microbiology & Environmental Monitoring testing.
  • Ensuring that OOS/MDDs and OOT investigations are initiated and completed to the correct standard.
  • Training and upskilling of analysts within Microbiology Testing with a handson training approach for analysts in theoretical aspects of Microbiology, and techniques by means of demonstration and supervision, using test methods, SOPs, and other documentation.
  • Performing formal competency assessments of performance, (e.g., Sterility testing, etc.).
  • Participate in the selection and procurement of analytical test equipment and participation in equipment qualification (e.g., review of qualification documents).
  • Adhering to Pharmaceutical Quality System (PQS) requirements (e.g., SOPs, CAPAs, Deviations, Risk Assessments, and Change Controls).
  • Participating in quality audits and closing out gaps and findings.
  • Participating in Microbiological & EM testing related to technology transfers from other vaccine manufacturers and other project activities.
  • Participating in inspections, investigations, risk management, and quality review exercises.
  • Ensuring that DMS queries are attended to and resolved within a reasonable time as the System Owner.
  • Coordinating Data Integrity in the QC Laboratory with reference to Microbiological & Environmental Monitoring testing with new and upcoming technologies (e.g., LIMS, new hardware and software programs, new technologies), when necessary.
  • Coordinating Microbiological & EM Risk assessments in accordance with cGMP guidelines (e.g., ICH Q9, ICH Q10, etc).
  • Assisting with the implementation of the site Containment and Control Strategy (CSS), with reference to Microbiology & Environmental Monitoring.

Application Deadline: 11 August 2023

_Disclaimer:
_

  • By submitting your CV and personal information, you agree that Biovac may utilise this information to conduct and complete our recruitment process, which entails distributing your information to all internal recruitment participants and service providers who forms part of the process._
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