Website The Biovac Institute
The Biovac Institute requires a Quality Assurance Officer 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 QAO Section Head.
The Key Performance Areas for this position include:
- Ensure that activities and processes within facility are in compliance with the cGMP requirements for that area ie. Production, Quality Control, Warehouse and distribution;
o Ensure presence in area of responsibility to ensure area is compliant with cGMP and Biovac requirements
o Ensure that any deviations from procedures and processes are promptly recorded and investigated in a timely manner
o Participate in the investigation of deviations, discrepancies or test failures as required.
o Ensure that the quality of the investigations and root causes defined are technically and scientifically sound and are based on data and facts. Conduct or assist in root cause analysis and investigations
o Review and approval of procedures within area of responsibility.
o Ensure that the processes and procedures in place meet the cGMP guidelines, that the flow and sequence are correct and that they are fit for purpose
o Perform QA browsing activities within areas to assess their adherence with cGMP and document any observations and areas for improvement.
o Review changes proposed in area of responsibility in consultation with the initiators as required.
o Participate in Quality Compliance Forum meetings for areas of responsibility and assist in coordination with other stakeholders and mitigation to resolve any issued preventing DR, CCN, CAPAs to meet close out timelines
o Perform internal audits as required according to audit program to determine compliance with GMP requirements.
o Generate audit reports – both initial and final close out reports
- Support QA department with Regulatory audits and other 3rd party audits
o Assist HOD on follow up and close out on audit findings as per defined timelines as per agreement of stakeholders
o No critical audit findings on site
- Perform an assessment of trend data associated with defined areas of responsibility for defined processes and environmental monitoring where applicable
- Review and approve (pre and post approval) on requalification documents for areas of responsibility
- Perform system reviews for process and equipment as defined in the system process review schedule to ensure that the equipment and processes assessed are under control and compliant with validation lifecycle requirements.
- Participate in the vendor certification process as required.
- Ensure that development plans as agreed with line manager on IDP are implemented and goals achieved
- Identify risks in area of responsibility and within role and mitigate where appropriate.
o Inform HOD, Section Head and relevant stakeholders of risks identified and Identify solutions to mitigate risk
o Update HOD and Section Head on mitigation of risks conducted where applicable
- Assesses and ensure that best ways of working are in place for QCF meetings
- Continuous evaluate and improve systems in area of responsibility
Qualifications and Skills Required:
- Degree or diploma in Pharmacy, Biotechnology, Biological Sciences or similar field.
- Minimum of 3 Years of experience in Quality Assurance in a successful pharmaceutical cGMP environment or equivalent industry
- Knowledge of sterile production and facilities preferable.
- Expert knowledge of current good manufacturing practices & good laboratory practices and the associated industry guidelines is required.
- Experience in application of guidance documents from the appropriate regulatory and advisory agencies, particularly SA GMP, PIC/S, WHO, EU / EMEA,
- Experience in auditing will 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 email@example.com by 31 May 2017