The Biovac Institute requires a QC Supervisor – Microbiology to contribute to its mission of establishing local biological and vaccine manufacturing capability at its Cape Town based site. Being the only one of its kind in South Africa, Biovac strives to respond to the vaccine needs of the developing countries, specifically South Africa and Sub Saharan Africa. 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 Section Head: Biological Testing.
Key Performance Areas for this position include:
- Co-ordination of microbiological testing (e.g. bioburden, identification – Vitek, sterility testing, growth promotion testing, closed container integrity testing, endotoxin) environmental monitoring and other tests.
- Review of laboratory raw data and investigation of out of specification results.
- Trend analysis.
- Compilation of analytical method validation/verification protocols and reports and co-ordination of the testing.
- Writing, reviewing and updating of material and product specifications, 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.
- Adherence to QA quality system requirements e.g. CAPAs, deviations, change controls, risk assessments.
- Participation in quality audits and addressing audit findings.
- Performance management of staff.
- Budget, expense and capacity management.
- Participation in improvement initiatives and projects.
Qualifications and Skills Required
- At least 3 years experience in a pharmaceutical QC laboratory or routine microbiology laboratory or equivalent.
- Experience in sterility testing and operation of an Isolator would be an advantage.
- Supervisory experience in a pharmaceutical QC laboratory or similar position would be an advantage.
- Quality and regulatory compliance knowledge, i.e. MCC and WHO would be an advantage.
- Experience in having faced successfully local quality audits would be an advantage
- Diploma or degree in Microbiology, Biochemistry, Biotechnology or related subject
- May require some occasional standby and/or weekend work to accommodate schedules and/or project timelines.
- Own reliable transport would be an advantage.
All positions will be filled in accordance with our Employment Equity policy as The Biovac Institute is committed to the pursuit of excellence, diversity and redress.
Interested persons to kindly submit their CV’s to www.biovac.co.za/register-apply-today by 07 August 2017
Kindly note that by submitting your application for this career opportunity you agree that Biovac may use your application for the purpose of the recruitment and selection of the said position and this information may be shared with the relevant stakeholders in the business