Job Opening at The Biovac Institute

Job description

The Biovac Institute requires a VLP Section Head to contribute to its mission of establishing and maintaining effective value creation for its biological and vaccine partners and stakeholders within its current and future commercial footprint.

Being the only one of its kind in South Africa, Biovac strives to respond to the sterile injectable needs, particularly related to vaccines and other biologicals, South Africa, Sub Saharan Africa and other developing countries.

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 Production Manager.

Summary of role

• Visual inspection, labelling and packing (VLP) and storage of vaccines & related items in accordance with cGMP, SOPs the relevant regulatory legislature (Medicine Control Act, Pharmacy Act & Occupational, Safety and Health Act).
• Management of the section’s delivery in alignment to local and international pharmaceutical quality system requirements to ensure cGMP at all times.
• Continuously builds and supports a sound quality assurance culture in the section aligned to cGMP and within Biovac.
• Project activities relating to the section according to required standards and agreed time lines.
• Manufacturing output that is aligned with the annual commercial manufacturing plan, quality requirements and agreed time lines.
• Participation in quality audits and support to validation teams and close out of findings in area of responsibility
• Ensures compliance in accordance with Medicines and Related Substances Act 101 of 1965, Pharmacy Act 53 of 1974, and Biovac’s policies, procedures and other applicable laws.
• Achieves high performance in the VLP Section, against the Section’s deliverables and provides the required support to other areas in the business to ensure overall company success.
• Provides strategic, operational and behavioural mentoring and guidance to direct reports.
• Ensures the relevant expertise and current Good Manufacturing Practices (cGMP) compliance is achieved within the team.
• Ensures service delivery to all stakeholders internally, as well as externally.
• Ensures effective employee relations with regards to conduct and performance in accordance with the company values as well as performance culture. Ensures that people related matters are addressed in line with labour legislation, company policies and practices.
• Align departmental focus areas and outputs to the business’s objectives
• Conduct business, cross functional and departmental planning and execute activities within own scope of accountability.
• Adequate capacity planning and performance delivery in line with strategic, tactical and operational plans
• Role profiling, goal setting and performance management of managers and staff within the department.
• Develop and implement a knowledge management infrastructure within the department to ensure Intellectual Property is effectively maintained
• Ensures growth, succession & retention of departmental talent.
• Accountability for own and team's personal and professional learning & development to ensure technical and leadership bench strength within the department
• Ensures accurate delegation of ongoing operational activities in the event of key staff members’ absence.
• Conducts effective employee relations in accordance with labour legislation, company policies and procedures and address any performance and conduct concerns and risks timeously.

KPI Development

• Resource & Capacity Planning & Management
• South African Labour Legislation
• Coaching & Mentoring of peers & staff.
• Shared accountability for achieving the site’s tactical plans and mitigation of any risk to the site operation including workflow, ethics, quality,finances, regulatory compliance and other material company requirements.
• Ensures robust, holistic, timeous and achievable planning by VLP to meet the commercial manufacturing plan in accordance with the company’s strategic drivers and deliverables.
• Ensures sufficient resource and capacity planning in order to achieve goals within the timeframes as determined and within the budget provided.
• Identifies and continuously presents key opportunities and synergies that will improve and/ or expand the operation within own and/ or other departments.
• Monitors progress and learning on an ongoing basis to ensure adequate return on time and resources invested.
• Proactively identifies general business as well as area of responsibility- related risks and finds ways to mitigate these.
• Ensures effective and comprehensive planning of the sections’ financial forecast and budget
• requirements
• Instils a cost conscious culture and responsible investment in initiatives that add value to the business and fit within the financial plan and business priorities
• Drives continuous improvement plans and priorities through the implementation of appropriate tools or methodologies in order to proactively manage risk, reduce wastage and to improve quality on site
• Lead or participate in departmental and/ or site wide projects
• Monitoring & reporting on key operations, critical numbers and key performance indicators that impacts the business’s short, medium and long term objectives.
• Proactively mitigates risks and finds solutions where possible
• Ensures that products are produced and stored according to the appropriately authorised documentation in order to obtain the required quality.
• Ensures that the production records are reviewed and signed by authorised persons before they are sent to the Quality Assurance Department.
• Ensures that the maintenance of the department, premises, qualification, validation and calibration of the equipment is up to date before permitting operations to commence.
• Up-to-date knowledge of visual inspection, packing and labelling of small volume parenterals/vaccines, processes and relevant equipment.
• Ensures that all activities are correctly documented and controlled.
• Liaises with other project team members for design and procurement of small pieces of equipment and consumables.
• Reviews / approves project-related documents and is accountable for all project-related VLP documents.
• Ensures overall coordination and evaluation of the section, by maintaining cGMP standards.
• Ensures that products are inspected, labelled, packed, and stored using the appropriate documentation in order to obtain the required quality.
• Ensures that documentation is current and assists in the maintenance and compilation of new documentation according to cDocP.
• Ensures that all department specific documentation is maintained and managed according to CGMP and GDocP.
• Identifies shortfalls or potential problems and addresses it appropriately.
• Building own, team and site’s GMP Knowledge and Compliance
• Participates in building quality objectives and provide ongoing metrics that directly support the achievement of such objectives.
• Participates in building a sustainable Quality Culture on site and proactive mitigate risks that may negatively impact quality or escalate these appropriately.
• Establish and maintain a state of control related to quality management within the department
• Ensuring that the department is audit ready through closing out audit findings timeously
• Ensures Deviations, Change Controls, CAPAs are handled effectively and per company procedures and time lines.
• Advocate continuous improvement within own department as well as cross functionally.
• Ensures that team’s training is continuously updated, reviewed and up to date 

Other requirements

After hours availability, reliable transport, ability to travel nationally and internationally.

Competencies

Technical

• Excellent understanding and working knowledge of cGMP, pharmaceutical packing processes and requirements.
• Detailed knowledge of pharmaceutical industry standards and guidelines in GMP and Quality and Manufacturing.
• Documentation Management
• Inventory Management
• Environmental, Health & Safety Management
• Statistical Trending & Data Analysis
• Metric Development & Report Writing 
• Coaching & Mentoring of peers & staff
• Review & Auditing Skills
• cGMP vaccine manufacturing- quality and regulatory compliance knowledge, i.e. MCC and WHO
• Total Quality Management & Quality Management Systems
• Data development, trending & reporting
• Coaching & mentoring peers & staff

Qualifications

Required:

Bachelor’s degree or diploma in pharmaceutical packing/packaging or applicable scientific field e.g. biological sciences/process engineering.

Preferred:

Management qualification and/or BPharm.
Recognition is given to prior learning and practical experience in management of pharmaceutical manufacturing activities.

Experience & Industry Knowledge

Required

Supervisory / management experience in cGMP vaccine / biotech l or pharmaceutical manufacturing.
Experience in and knowledge of quality and regulatory compliance, i.e. MCC and WHO

Preferred

• At least 5 years’ experience at middle to senior management level of pharmaceutical packing or applicable pharmaceutical processes.
• Experience in quality and regulatory compliance within a cGMP facility.
• Experience in having faced successfully local and/ or international quality audits.
• Experience in general business management within a commercial environment
• Participation in developing a departmental budget and monitoring expenditures.