Release and Outsource Manager

6 months ago

Cape Town, South Africa Biovac Full time

**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

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