Qc Manager

2 weeks 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 Quality Control Manager to join a goal-oriented team.

**QUALIFICATIONS NEEDED**:

- Degree or diploma in Chemistry / Analytical Chemistry / Biochemistry /Biotechnology or equivalent.

**NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE**:

- At least 5-8 years of experience in the sterile vaccine/pharmaceutical/biotech manufacturing industry.
- At least 2-3 years of experience at the middle management level.
- Experience in quality and regulatory compliance within a cGMP facility.
- Business Operational Planning.
- Program and Project Management.
- Developing departmental budgets and monitoring expenditures for multiple projects.
- Experience in Chemistry, Microbiology, and Biochemistry disciplines.

**KEY DUTIES & RESPONSIBILITIES OF THE ROLE**:

- Monitor QC compliance against cGMP and Biovac s Quality Management System.
- Manage internal stakeholders and customer relations through effective collaboration.
- Ensure all QC activities are documented and reviewed for accuracy timeously and pragmatically, including QC specifications, SOPs, work instructions and workflows, master batch and ,packaging documents,
- Ensure that the department equipment used for testing is adequately maintained and calibrated, qualified and that the relevant checks are performed to ensure compliance with cGMP requirements in the department.
- Monitoring and control of the production and testing environment, by monitoring and trending clean rooms, utilities, and products and investigating and/ or documenting any OOS/MDD and OOT investigations are investigated with the required timeframe.
- Managing the Environmental Monitoring (EM) program for the manufacturing facilities.
- Approving and monitoring contract laboratories, contract manufacturers, and suppliers, when required.
- Manage the departments procedures, protocols, and specifications for quality-controlled goods, storing of materials, sampling instructions, test methods, and data sheets.
- Ensure Analytical method validation is in place for investigational and registered products.
- Overall management of sampling and testing activities, data, and results within the department and communicating and mitigating risks with affected stakeholders accordingly.
- Ensure that retention samples are managed ensuring storage at the correct parameters and conditions.
- Managing the Stability testing program.
- Escalate risks identified through test results to management that influence the quality of the product or the quality management system.
- Participate in inspections, and audits (internal and external) investigations, risk management and quality review exercises.
- Ensure that the correct establish expiry periods and storage instructions are incorporated onto the labeling of starting materials,
- Participate in initial and periodic process validation studies to demonstrate that materials, methods, processes, and equipment are capable of doing what they purport to do, to ensure processes are effective over the range of variation selected for a particular processing parameter.
- Manage the Operational Expenditure (OPEX) of the department to control expenses against approved budgets.
- Manage the inventory levels for the QC department (e.g., consumables, reagents, reference standards, and cultures) to ensure HLIP testing occurs as per schedules.
- Manage testing related to Validations, Qualification, and Method Transfer as per respective plans with the associated documentation (e.g., protocols and reports).
- Lead and identify continuous improvement projects to optimize testing and execute project activities according to agreed project timelines and within cGMP requirements.
- Ensure that OOS and OOT investigations are initiated and completed to the correct standard within the required due dates.
- Ensure that the maintenance of the department, premises, and equipment to ensure optimal operation at all times.
- Liaison with suppliers on technical issues where applicable.
- Managing new projects and techniques through technology transfer when required (e.g., Cell bank management, etc.).
- Ensure that the department testing regime complies with Data Integrity requirements.
- Ensure that the company's Containment Control Strategy is implemented and maintained.

**Application Deadline: 11 August 2023**

**_Disclaimer: _**
- By submitting your CV and personal information, you agree that Biovac may utilise this information to conduct and complete our recruitment process, which entails distributing your information to all internal recruitment participants and service providers who forms part of the process._

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