Job Description

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 Supervisor: Environmental Monitoring to join a goal-oriented team

QUALIFICATIONS NEEDED:

Required:

• Bachelor's Degree in Microbiology, Biotechnology, Molecular Biology, Biochemistry, or related field.

Preferred:

• Recognition is given to Prior Learning and practical experience

Experience needed to deliver the role seamlessly:

Required:

• At least 5 years' experience in vaccine / pharmaceutical / biotech manufacturing industry with QC Laboratory experience.
• At least 1 years' experience at supervisor level.
• Experience in quality and regulatory compliance within a cGMP facility

Preferred:

• Working with knowledge of Pharmaceutical Manufacturing related legislation
• Experience in aseptic (sterile) manufacturing and quality control
• Experience in having faced successfully local and/ or international quality audits

KEY DUTIES & RESPONSIBILITIES OF THE ROLE:

Core Technical Delivery

• Planning and coordinating routine EM and interpretation

• Compiling data trends, data analysis and associated reports related to EM to the correct standard and on time,

• Reviewing of EM results, laboratory raw data and logbooks, including OOS/MDDs and or OOT results from internal and/or external testing related to
• SME on the EM management system (SherpaPharma); implementing and managing sampling plans, locations, samplers, devices, media and results
• Ensuring that OOS/MDDs and OOT investigations are initiated and completed to the correct standard,
• Ensure Deviations, Change Controls, CAPAs related to EM are handled effectively,
• SME on EM during company audits

• Training and upskilling of QC Technicians and analysts

• Training QC Technicians and analysts on theoretical and practical aspects of EM (this includes strategic planning of the EM plan, the sampling process, incubation, and interpretation of results) with hands-on training approach by means of demonstration and supervision using test methods, SOP's, and other documentation and formal assessments,

• Implementing a programme for formal competency assessments of sampling and gowning

• Selecting analytical test equipment for procurement and participating in equipment qualification e.g., review of qualification documents from an EM perspective,

• Assisting in writing and updating of material and product specifications and test methods and standard operating procedures related to EM,

• Participating in the selection and procurement of analytical test equipment and participation in equipment qualification (e.g., review of qualification documents),

• Adhering to Pharmaceutical Quality System (PQS) requirements (e.g., SOPs, CAPA's, Deviations, Risk Assessments, and Change Controls),

• Participating in quality audits and close out gaps and findings,

• Participating in inspections, investigations, risk management and quality review exercises,

• Participating in EM related to technology transfers from other vaccine manufacturers and other project activities.
• Co-ordinating Data Integrity in the QC Laboratory with reference to EM with new and upcoming technologies (e.g., Sherpa, LIMS, new hardware and software programs, new technologies), when necessary,

• Co-ordinating EM Risk assessments in accordance with cGMP guidelines (e.g., ICH Q9, ICH Q10, etc),

• Assisting with implementation of the site Containment and Control Strategy (CSS), with reference to EM.

Data Integrity Compliance

• Ensure all laboratory data is recorded, reviewed, and stored in accordance with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available).

• Promote a culture of data integrity by training staff on proper documentation practices and electronic data handling.

• Monitor and audit data management systems to detect and prevent data manipulation, omissions, or unauthorized access.

• Support implementation of secure, validated systems for electronic records and signatures in compliance with 21 CFR Part 11 and other applicable regulations.

People Management

• Management, coordination and development of QC Technicians
• 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
• 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
• Ensure accurate delegation of ongoing operational activities in the event of key staff members' absence.
• Conduct effective employee relations in accordance with labour legislation, company policies and procedures and address any performance and conduct concerns and risks timeously.

Application Deadline: 30 June 2026

If you do not receive a response from us within three weeks after closing date, please understand that your application was not successful.

Disclaimer:

Dear Applicant, we appreciate your interest in joining our organization. It is imperative for us that you understand how we handle your information. We are committed to ensuring the security and confidentiality of the information you provide. Your personal details will be collected for the sole purpose of the application process and will be used strictly for that purpose. By applying, you acknowledge and consent to the collection, use, and protection of your personal information in accordance with our privacy policy. If you have any inquiries or concerns, our Human Capital department is available to provide clarification. We look forward to reviewing your application.''

For detailed information on data handling, please review our privacy notice:

https://www.biovac.co.za/wp-content/uploads/2022/08/published_Biovac-Privacy-Notice-20220617-2306-en.pdf