Quality Assurance Operations Section Head

Quality Assurance Operations Department

Pinelands, Cape Town

The Biovac Institute requires a Quality Assurance Operations Section Head 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 Quality Assurance Operations Manager

The Key Performance Areas for this position include:

• Section Planning
• Section Capacity Planning
• Cross Section/ departmental Synergy
• Progress Monitoring & Reporting
• Company and Departmental Annual Plan & Progress Communication to Department
• Performance Management (performance agreements in place, performance reviews conducted, consistency requirement upheld)
• Growth, Succession & Retention Implementation
• Driving team behaviour
• Culture Management:  (Manage staff employment, performance, conduct in accordance with Legislation (LRA, BCEA, POPI))
• Ensure that Quality Management systems i.e. Deviations, change controls, CAPAs and Notifications are in place and under control;

o   Participate in the investigation of deviations, discrepancies or test failures:

o   Ensure compliance to quality systems are monitored via QCF departmental meetings

o   Ensure monthly Quality Council metrics is submitted timeously

o   Write and submit annual quality management system review report to senior management.

o   Review and approve quarterly metrics reports

• Ensure a Risk Management process is in place and risk assessment s conducted and mitigated where appropriate
• Ensure that a vendor approval system is in place for goods and services;

o   Evaluate and assess the vendor’s suitability through vendor certification process and by conducting site audits where applicable (technical assessments), including quality systems or assessing appropriate vendor GMP checklist responses and ensure all necessary information is received to enable the material or service to be used on site.

o   Audit and approve contract manufacturers, where these are to be employed

o   Ensure new vendors are placed on audit plan and vendor audits conducted as per audit plan; Unsatisfactory vendors removed

• Establish and maintain an active internal audit program to determine compliance with GMP requirements; observations found followed up and close out within defined time frames as per agreement of stakeholders
• Support Quality Assurance Systems department with Regulatory audits and other 3rd party audits; assist HOD on follow up and close out of audit findings timeously
• Review and Approve out of specification investigations, out of trends investigations, protocols and reports within defined timelines as stated in SOPs.    
• Write where applicable, review and approve Validation plans (VPs) and reports.
• Review, Approval and sign-off  all operational documents and records e.g.. System and component Impact Assessments, GMP reviews, Design reviews, Risk Assessment, IQ, OQ, PQ, Performance testing, Aseptic Process Validation, Process Validation, Analytical Methods Validation, Cold-chain Packaging and Cleaning Validation documents, including both Protocols and Reports to ensure compliance with site approaches, cGMP and regulatory agency requirements.
• 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
• Ensure annual system and process reviews are performed, issues addressed, reports approved and register maintained as per defined timelines
• Ensure annual system in place for the generation and approval of Product Quality Reviews as per defined timelines
• Provide information and appropriate documentation to support update of Site Master File
• Ensure control of storage and management of all strategically important and GMP viral seed stocks, seed lots and cell banks used for manufacturing at The Bivouac Institute is handed over to Logistics as agreed June 2014.
• Assist HOD with quality related complaints investigations when required
• Assist or perform Investigations in the event of a medicines recall and compile quality related reports within defined timelines.
• Assist in investigations in reported adverse drug reaction and provide quality report to Pharmacovigilance officer
• Define project deliverables in conjunction with HOD and project managers.

o   Participate in projects as/when required

o   Ensure Projects deliverables delivered as per agreed timelines and quality

o   Delegate project deliverables to staff in section where appropriate according to skill or skill development

• Act as QA Operations Manager with full delegated responsibilities in the absence of QA Manager and as a signatory on a day to day basis as required.

·         Transformation                                                                                                                                             

·         Budgeting & Expense Management:

·         Identify departmental risks and mitigate where appropriate.

·         Innovation and Improvement initiatives and projects

Qualifications and Skills Required:

·         Degree or Diploma in Microbiology / Biotechnology, Pharmacy or equivalent.

·         5 years’ experience in vaccine / biotech / pharmaceutical industry or equivalent would be advantageous.

·         3 years supervisory / management experience in cGMP vaccine manufacturing / or similar position.

·         Sterile experience will be an advantage

·         Quality & regulatory compliance knowledge, i.e. MCC and WHO.

·         Experience in general business management.

·         Sound technical ability and hands on approach.

·         Experience in having faced successfully local and international quality audits.

Other requirements

• 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 recruitment@biovacinstitute.co.za