Microbiology Supervisor at The Biovac Institute

Job description

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

Other Requirements

• May require some occasional standby and/or weekend work to accommodate schedules and/or project timelines.
• Own reliable transport would be an advantage.