Release and Outsource Manager

**BIOVAC** is one of the leading sterile vaccine manufacturers rooted in Africa, with our core purpose being to "protect life". We are looking to hire a dynamic, passionate, confident, proactive, and meticulous Release & Outsource Manager to join a goal-oriented team. **QUALIFICATIONS NEEDED**: - Degree or Diploma in Pharmacy. **NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE**: - At least 5-8 years of experience in the vaccine/ biotech/ sterile manufacturing industry, with 4 years of experience in the release of sterile products. - At least 3-5 years of experience at the management level. - Experience in quality and regulatory compliance within a cGMP facility. - Experience in aseptic (sterile) manufacturing and Batch release. - Business and operational planning. - Program and project management. - Participation in developing a departmental budget and monitoring expenditures for multiple projects & funding sources. **KEY DUTIES & RESPONSIBILITIES OF THE ROLE**: - Full accountability and responsibility for all areas within the Release and Outsource department consisting of Release, Outsource, Vendor Management, and Projects. - Overall management and implementation of specified QA processes and document systems including Product Quality Complaints, Product Quality Reviews, Adverse Events Following Immunization, Self-Inspections, National Regulatory Audits, Supplier Audits, Recalls, Artwork, and Vendor Management. - Ensure that departmental planning activities occur. **Vendor Management & Outsourced Activities** - Ensure that the vendor management program is in place and in compliance with cGMP. - Ensure that the Vendor Management program is effective in purchasing materials and/or services from approved vendors by integration of QA, QC and Procurement through regular monitoring and approved vendors. - Ensure that a risk-based approach for the Vendor management program is followed. - Recommend approval or disapproval of vendors based on compliance assessment and escalate the disapproval to HOD: Quality and the RP. - Ensure that an approved vendors list is maintained. - Become a contact person for Biovacs Contract Manufacturing Organizations (CMO) for work coming in and going out. - Liaise with the Responsible Pharmacist for all incoming products from CMOs. - Manage the audit plan and ensure that auditors are appointed. - Ensure continuous training of auditors within Biovac. - Lead quality and for cause audits for vendors and Biovacs CMO to ensure timely audits, communication, and resolution. - Ensure that procedures and specifications are appropriate and followed including the procedures and specifications of contract manufacturers, contract laboratories, etc. - Ensure Annual Reports are completed where required. - Ensure that there are written contacts for all CMOs, and they are updated regularly when required. - Ensure that all current master documents which include but are not limited to specifications, and batch records are available and maintained as per SOP. - Ensure that deviations from the CMO are communicated to the site and appropriate departments are notified and the actions required and executed. - Ensure that change notifications from the CMOs and suppliers are communicated to the site and appropriate departments are notified and the actions required and executed. - Design, plan, implement maintain, improve, and actively participate in the development of product exports within Biovac. - Work with the Commercial department to ensure that exported product complies with cGMP and SAHPRA guidelines. - Ensure that all agents that Biovac exports products have Quality contracts and adhere to the cGMP of their country. - Ensure the department liaises with internal stakeholders on PPM documentation that is required. - Ensure that there are tracking mechanisms for artwork and report status on all in-process design and printing. - Ensure Liaise with Printers on artwork design and printing. - Ensure that artwork design and development support is given to Project teams. - Overall management and implementation of specified QA processes and Internal Audits, National Regulatory Audits, and External Audits. - Ensure compilation of Annual Product Reviews for all products processed on-site during the preceding year. - Review and approve documentation within defined timelines as stated in SOPs. - Benchmark against quality standards of industry and regulatory bodies and create awareness of GMP updates, as appropriate throughout the site. - Maintain an active internal audit program to determine/ensure compliance with cGMP requirements. - Manage customer and regulator audits and ensure tracking and closure of findings, whilst maintaining appropriate communication between Biovac and auditors. - Ensure that risk assessments are conducted and participate is assessments and mitigation where needed. **Release** - Ensure that appropriate manufacturing controls, including master manufacturing and packing documents, are in p