QC Analyst: Biological Testing

Website The Biovac Institute

The Biovac Institute requires a Quality Control Analyst – Biological Testing to contribute to its mission of establishing and maintaining effective value creation for its biological and vaccine partners and stakeholders within its current and future commercial footprint.

Being the only one of its kind in South Africa, Biovac strives to respond to the sterile injectable needs, particularly related to vaccines and other biologicals, South Africa, Sub Saharan Africa and other developing countries.

This is a particularly exciting time for the company as it continues to grow, strengthen and build on its success and further develop its capabilities, products, services and market diversification.

The successful incumbent will report to the QC Supervisor – Biological Testing.

Summary of role

  • Routine testing of raw materials, in process samples and product samples for biological (including endotoxin testing and immunological assays e.g. ELISA, nephelometry, immunodiffusion).
  • Assistance with raw materials, in process samples and product samples for microbiological testing (including utilities testing, medial fills and environmental monitoring).
  • Knowledge of Immunochemistry assays will be advantageous.
  • Participating in technology transfers from other laboratories.
  • Test verification and validation.
  • Continually strive to deliver solutions through team work that ensures continuous improvement through innovative solutions.
  • Achieving / maintaining of the facilities and processes in full compliance with the current regulations and guidelines – both local and international.
  • Participating in project teams and supporting other relevant organisational departments and/or teams.
  • Ensures compliance in accordance with (Medicines and Related Substances Act 101 of 1965, Pharmacy Act 53 of 1974) and the organizations policies, procedures and other applicable laws.
  • Participation in quality audits and support to validation teams.
  • Effective implementation / maintenance of quality systems & safety systems.
  • Ordering and stock control.
  • Equipment monitoring and maintenance.
  • Sampling of utilities e.g. water.
  • Preparation of sample containers.
  • Sample receipt.
  • Compiling laboratory reports.
  • Good Laboratory Practice.
  • SME Duties.
  • Quality Systems.
  • Trend analysis.
  • Sectional Risk Identification & Mitigation.
  • Innovation and Improvement Initiatives and Projects.

Qualifications

  • Diploma or Degree in Microbiology, Biochemistry or Biotechnology or equivalent
  • NQF level 7

Knowledge & Experience Required

  • Minimum experience required for this position is 1 – 3 years’ relevant laboratory experience, preferably in a GMP environment or related.
  • Must demonstrate competency with laboratory skills, including documentation.
  • Experience with reviewing of raw data results, logbooks and documents would be advantageous.
  • Experience in deviations, change controls and CAPAs would be advantageous.

Other Requirements:

  • May require some occasional off shift and/or weekend coverage to accommodate schedules and/or project timelines. 

Competencies:

Technical

  • General Immunochemistry/ Microbiology knowledge

Generic

  • Good Time Management
  • Attention to Detail
  • Good Written and Communication Skills
  • Flexibility and adaptability in responding to change

If you are interested in applying for this opportunity then forward your application to recruitment@biovac.co.za  by close of business on the 14 July 2018

Disclaimer: Biovac supports employment equity principles and for this reason, all vacancies are filled in accordance with our diversity management strategy and equity plans.  Furthermore, by submitting your application you agree that Biovac may use your information and share relevant information with our recruitment and selection stakeholders involved in this process.  

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