The Biovac Institute requires a Quality Assurance Operations 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. Please note that this is a six month fixed term contract only
The successful incumbent will report to the Quality Assurance Operations Section Head
The Key Performance Areas for this position include:
Quality Management systems
Participate in the investigation of deviations, discrepancies, root cause investigations or test failures as required.
- Support Warehouse, Stores and Production – Visual inspection, Labelling and Packaging operational areas of responsibility in closure of deviations, change controls, CAPA and investigations.
- Review and approve Corrective Actions and Preventive Actions (CAPA) in order to meet compliance requirements.
- Review and approve change controls for quality and regulatory compliance impact and determine requirements for implementation
- Ensure that vendor approval is obtained for new goods or services in areas of responsibility
- Assess the vendor’s suitability through vendor certification process by reviewing postal audits and supporting site audits where applicable.
- Follow up and ensure close out of internal audit observations within defined time frames as per agreement of stakeholders
- Support QA Systems department with Regulatory audits and other 3rd party audits
- Ensure deep and holistic understanding of allocated area(s) of responsibility to ensure effective closure of critical audit findings on site
Ensure compliance to all applicable regulations and internal procedures by proactively interpreting regulatory and quality requirements and determining way of working.
- Coach and provide QA leadership to areas of responsibility on quality compliance requirements.
- As a member of the QA team be able to contribute in discussions on relevant topics and communicate closely with offer departments.
- Review GMP documents such as SOPs, WI, reports, etc.
- Review batch records for compliance and adherence to GMP and ensure that all associated change controls and deviations are present and closed before authorisation and release by responsible pharmacist,
- Track any quality issues at regular departmental meetings, in order to support timeous closure.
- Conduct Quality Forum meetings within areas of responsibility.
- Perform QA browsing of areas of responsibility and ensure that observations are documented and followed up. Browsing activities include (but not limited to):
- Daily shop floor presence in order to improve interaction with shop floor and greater visibility to facilitate shop floor support
- Monitoring and review of DMS, including alarms and trends
- Monitoring and review of equipment that require calibration and/or verification
- Verification of critical process parameters after breaks and/or interruptions to ensure that the required compliance has not been compromised
- Monitoring and review of any recurrent issues that may indicate a systemic problem
3 years’ experience in vaccine / biotech / pharmaceutical industry or equivalent.
- Quality & regulatory compliance knowledge, i.e. SA GMP, PIC/S and WHO would be an advantage.
- Sound technical ability in the field of operational Quality Assurance.
- Sound knowledge of warehousing and packaging would be advantageous
- Experience in having faced successfully local quality audits would be an advantage
Technical Skills Required
Quality Assurance experience in a pharmaceutical environment
- Familiarity with warehousing and packaging
- Current GMP and Quality Management principles, guidelines and standards
- Quality Management Systems and system interactions
- Experience in auditing
Communication skills (verbal & written)
- Attention to detail
- Good documentation and record management
- Analytical thinking
- Ability to research independently
Time Management skills
- Well organized and Reliable
- Service orientation and Responsiveness
- Compliance orientation
Negotiation and collaboration
- Positive team contribution
- Networking with partners internally, external Coaching and training skills
Local and international travel may be required.
- Own, reliable transport required for possible standby and shift work.
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 firstname.lastname@example.org by 31 May 2016
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