Biological Testing Supervisor at The Biovac Institute

Job description

Key Performance Areas for this position include

People Management

• Achieve high performance, through the Quality Management team, against the Quality Unit’s deliverables and provide the required support to other areas in the business to ensure overall company success
• Provide strategic, operational and behavioural mentoring and guidance to direct reports
• Ensure the relevant expertise and current Good Manufacturing Practices (cGMP) alignment exists within the teams.
• Ensure continuous internal and external knowledge & skills development of the unit in line with on the job, legislative and best practice requirements
• Ensure adequate service delivery to all stakeholders internally, as well as externally
• Identify activities for delegation and empower functional managers with the required levels of decision making ability to ensure smooth running of the operations.
• Ensure effective employee relations with regards to conduct and performance in accordance with the company values as well as performance culture. Ensure that people related matters are addressed in line with labour legislation, company policies and practices.

Business Management

• Participate in building and reviewing the company’s short, medium and long term strategy
• Ensure a robust, holistic, timeous and adequate planning by the Quality Unit in accordance with the company’sstrategic drivers and deliverables
• Ensure sufficient resource and capacity planning in order to achieve goals within the timeframes as determined and within the budget provided
• Identify key opportunities and deliverables as required by own unit/ section or by other departments for cross functional synergies/ project work and oversee implementation
• Monitor progress and learning’s on-goingly to ensure adequate return on time and resources invested.
• Proactively mitigate general business as well as area of responsibility- related risks and find ways to mitigate these.
• Ensure effective and comprehensive planning of the unit/ sections’
• financial forecast and budget requirements
• Instil a cost conscious culture and responsible investment in initiatives that add value to the business and fits within the financial plan and priorities
• Drive 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
• Co-ordination of testing of starting materials, intermediates, final products and utilities.
• Review of laboratory raw data and investigation of out of specification results.
• Writing and updating of material and product specifications and test methods and standard operating procedures.
• Liaison with suppliers on technical issues where applicable.
• Maintaining laboratory operations at cGMP standards to ensure quality, safety and regulatory compliance.
• Ordering and stock control.
• Adhere to QA quality system requirements e.g. CAPAs, deviations, change controls.
• Participation in quality audits and close out gaps and findings
• Execute project activities according to agreed project timelines.
• Implementation of new tests and new technologies and participation in the qualification of related equipment within a project
• Participation in technology transfers from other vaccine manufacturers and other project activities.
• Test development, verification and validation

Quality Performance in terms of:

• Building GMP Knowledge and Compliance
• Building Quality Culture
• Establishing and maintaining a state of Control
• Driving Innovation and Continuous Improvement
• Driving Quality Risk Management
• Ensuring that area of responsibility is audit ready; closing audit findings”  
• Managing Deviations, Change Controls, CAPAs
• Quality Objectives: Drive the quality objectives.
• Ensure a timely and effective communication.
• Escalate quality issues to the appropriate levels of management.
• Improvement: Advocate continual improvement within department

Qualifications and Skills Required

• Diploma or degree in Analytical Chemistry or Chemistry or equivalent
• 3+ years’ experience in a pharmaceutical QC laboratory or routine microbiology laboratory or equivalent.
• Competency in the following testing techniques: TOC, HPLC, GC, ICP-OES, would be advantageous
• 1 years’ Supervisory experience in pharmaceutical quality control or similar position would be an advantage.
• Quality and regulatory compliance knowledge, i.e. MCC and WHO would be an advantage.
• Experience in having faced successfully local quality audits would be an advantage

Technical Competencies

• General business management
• Sound technical ability and hands on approach.
• Basic understanding of Legislation relating to documentation (BCEA/ LRA)
• Business processes (pharmaceutical and vaccine industry)
• Statistical literacy
• Proficient in Microsoft office packages
• Report writing ability
• Analytical skills
• Budgeting
• cGMP vaccine manufacturing- quality and regulatory compliance knowledge, i.e. MCC and WHO 
• Excellent report writing ability
• Detailed knowledge of pharmaceutical industry standards and guidelines in GMP, Quality and Laboratory Management
• Safety, Health and Environment (SHE): observation, monitoring, inspection, assesses and responding
• Technical report writing
• Good working knowledge of Microsoft office
• cGMP vaccine manufacturing- quality and regulatory compliance knowledge, i.e. MCC and WHO 
• Quality management Systems

 Generic Competencies

•  Coaching/ mentoring ability
• Relationship building with internal staff, managers and external providers
• Capacity planning
• Organisational skills and work planning
• Negotiation and influencing skills
• Partnering skills
• Customer focused
• Excellent communication skills – verbal and writing
• Proactive in mitigating risk
• Creative thinking around improvements and alignment to Best Practice and being progressive
• Financial Acumen
• Coordination skills
• Attention to detail
• Written communication and report writing
• Flexibility and adaptability in responding to change.

Other Requirements

• May require some occasional standby and/or weekend work to accommodate schedules and/or project timelines.
• Own reliable transport would be an advantage.

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.