Senior QC Analyst (Chemistry) at The Biovac Institute

Job Purpose

Responsible for testing activities including but not limited to:

1. QC testing of products, raw materials, utilities, and other samples.
2. Participation in technology transfers from other laboratories.
3. Introduction of new technologies.
4. Test verification and validation.
5. Continually strive to deliver solutions through teamwork that ensures continuous improvement through innovative solutions.
6. Achieving/ maintaining of the facilities and processes in full compliance with the current regulations and guidelines – both local and international.
7. Participating in project teams and supporting other relevant organizational department and/ or teams.
8. Participation in quality audits.

• Responsible to deliver QC Analyst services and solutions in alignment with pharmaceutical quality system requirements.
• Ensure compliance in accordance with the Medicines and Related Substances Act 101 of 1965 and the
• Pharmacy Act 53 of 1974, and the organization’s policies, procedures, and other applicable laws.
• Continuously support and prescribe to cGMP within Biovac.

Key Duties & Responsibilities

Core Technical Delivery (including but not limited to):

• Implementation of new tests and new technologies and participation in the qualification of related equipment.
• Test development, verification, and validation.
• Participation in technology transfers from other vaccine manufacturers and other project activities.
• Maintaining laboratory operations at cGMP standards to ensure quality, safety, and regulatory compliance.
• Stock control.
• Equipment monitoring and maintenance.
• Contributing to drafting, updating, proof reading and editing of procedures.
• Assist with Coordination of testing
• Routine testing (including utilities testing, raw material, in process and final product testing).
• Review of laboratory raw data and investigation of Out of Specification results.
• Compiling laboratory reports.
• Completing trend analysis templates as laboratory results are obtained.
• Participate in departmental audits and implement corrective actions where relevant.

Technical Competencies required to perform this aspect of the role:

• Computer Literacy
• Statistical Trending and Data Analysis
• Technical report writing skills
• Laboratory skills and techniques
• Detailed knowledge of pharmaceutical industry standards and guidelines in GMP, Quality and General Testing
• Quality management systems
• Environmental, Health & Safety Management

Quality Management

• Building own cGMP knowledge and compliance
• Participate in achieving the company’s quality objectives.
• Participate in building a sustainable quality culture on site and proactive mitigate risks that may negatively
• impact quality or escalate these appropriately.
• Ensuring audit readiness within own role through closing out audit findings timeously
• Ensure Change Controls are handled effectively
• Advocate continuous improvement

Technical Competencies required to perform this aspect of the role:

• cGMP knowledge
• Total Quality Management & Quality Management Systems
• Data development, trending & reporting

Generic Competencies required to perform this aspect of the role:

• Planning, Organising, Execution and Monitoring
• Creative Problem Solving and Innovation Skills
• Internal Stakeholder Management
• Action & Results Oriented
• Assertive & Resilient
• Ability to multitask
• Adaptable in Responding to change
• Influencing skills
• Proactive in mitigating risk
• Clear, timely and effective communication skills both verbally and in writing
• Analytical Ability

Experience & industry accreditation/ knowledge

Required:

• At least 1 - 3 years’ experience within the pharmaceutical/ biotech manufacturing/ vaccine manufacturing/ quality control or similar position.
• Demonstrated competency in laboratory skills, including documentation.
• Experience in quality management systems within a cGMP facility

Preferred:

• Knowledge of Pharmaceutical related legislation
• Previous participation in quality audits
• Experience in aseptic (sterile) manufacturing

Qualifications

Required:

• Diploma or degree in Analytical Chemistry, Biotechnology, Biochemistry or equivalent.

Recognition is given to Prior Learning and practical experience.

Other Requirements

• Own reliable transport