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 QC Lead: Laboratory Support and Compliance to join a goal-oriented team.QUALIFICATIONS NEEDED:

• Bachelors degree or diploma in scientific/quality discipline or equivalent.
• Recognition is given to Prior Learning and practical experience.

NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE:

• At least 6 years experience in vaccine/pharmaceutical/biotech/manufacturing industry within a QC environment.
• At least 3 years experience at middle to senior management level within QC.
• Experience in quality and regulatory compliance within a cGMP facility.
• Business and operational planning.
• Participation in developing a departmental budget and monitoring expenditures for multiple activities & funding sources.

KEY DUTIES & RESPONSIBILITIES OF THE ROLE:

• Ensures Plan, Track and execute all QC activities related to your team to ensure successful completion within agreed timelines.
• Set overall objectives and measurements for direct reports that is aligned to the company overall goals.
• Control of documentation and record keeping complies to latest standards.
• Ensure QC documentation, processes and equipment is compliant to Data integrity and ALCOA ++
• Monitors and ensures GxP within the laboratory.
• Ensures the laboratory training program is maintained and compliant to SOPs and guidelines.
• Continuous compliance of in-process activities to quality systems, procedures and regulatory requirements.
• Manage and co-ordinate the implementation of LIMS and continuous maintenance and improvement to latest guidelines and standards.
• Assist with Reviews and Monitoring materials for reduced testing.
• Budgets are set and managed accordingly.
• Compile ad hoc reports when required.
• Ensures that all monthly, quarterly and annual compliance reports are completed, reviewed and approved on time.
• Newly equipment is qualified and calibrated according to guidelines.
• Review/approve all documentation related to qualification, maintenance and calibration of QC facilities and equipment.
• Current equipment performance verified and maintained according to Pragma on time and pharmacopeial standards are met.
• Ensures that specifications, sampling instructions, test methods and associated QC documentation are available and effective.
• Reviews pharmacopeia, literature, guidelines to ensure the laboratory is working to the latest standards.
• Track and maintain QC activities for Deviations, Change control/requests, CAPA, OOS/OOT.
• Co-ordinate and manage the Stability Program for QC testing.
• Involved in setting budgets and capex.
• Integrate laboratory planning and maintain sample trackers
• Tracks samples from submission to release from laboratory.
• Ensures outsource of sample testing is done effectively and efficiently.
• Provides feedback and escalations to internal and external customers.
• Ensures that documents are available, controlled, retained and disposed of as per SOPs.
• Ensures that retention samples are maintained and compliant to current guidelines.
• Manage QC stock by implementing sufficient controls that will ensure availability and replenished as required for testing.
• Ensures cleaning of laboratory graded and non-graded areas.
• Ensures clean glassware is available for testing.
• Waste removal for QC laboratory.

Application Deadline: 09 April 2025If you do not receive a response from us within three weeks of submitting your application, 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.

Biovac