QC Analyst: Biochemistry

Job Purpose

• Responsible for Biological testing activities including but not limited to:

QC Biological testing of products, raw materials, utilities, and other samples.

Participation in technology transfers from other laboratories from a Biological testing

perspective.

Introduction of new technologies related to Biological testing,

Test verification and validation related to Biological testing,

Continually strive to deliver solutions through teamwork that ensures continuous

improvement through innovative solutions.

Achieving/ maintaining of the facilities and processes in full compliance with the current

regulations and guidelines – both local and international.

Participating in project teams and supporting other relevant organizational departments and/ or teams from a Biological testing perspective,

Participation in quality audits,

• Responsible to deliver QC Analysis services and solutions in alignment with Pharmaceutical Quality System (PQS) requirements, related to Biological testing,
• 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 build and support a sound quality assurance culture aligned to cGMP within Biovac,
• Responsible for QC Administrative activities to ensure product quality including but not limited to: Support to QC activities to ensure product quality.

Maintaining laboratory operations at cGMP, GLP standards to ensure quality, safety, and regulatory compliance.

Continually strive to deliver solutions through teamwork that ensures continuous improvement through innovative solutions.

Achieving/ maintaining of the facilities and processes in full compliance with the current regulations and guidelines – both local and international.

• Responsible to ensure that the QC department and its respective sections deliver 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 build and support a sound quality assurance culture aligned to cGMP within Biovac.

Minimum qualification(s) Required:

• Diploma or degree in Microbiology, Biotechnology, Biochemistry or equivalent (Micro & Biological Testing)
• Knowledge and understanding of relevant legislation and technical theory in field of study.

Preferred:

• Recognition is given to Prior Learning and practical experience.

Experience & industry knowledge Required:

• At least 1- 3 years’ experience in vaccine / pharmaceutical / biotech manufacturing industry

with QC Laboratory,

• Demonstrated competency in laboratory skills, including documentation,
• Experience in quality and regulatory compliance within a cGMP facility.

Preferred:

• Working knowledge of Pharmaceutical related legislation
• Previous participation in quality audits
• Experience in aseptic (sterile) manufacturing
• Working knowledge of testing techniques in instruments in Biological

Key Duties & Responsibilities Routine Activities (Including but not limited to):

• Implementing new tests and new technologies and participation in the qualification of related equipment related to Biological testing,
• Performing Biological testing, for analytical development, analytical verification, and analytical validation activities,
• Participating in technology transfers from other vaccine manufacturers and other project activities from a Biological perspective,
• Maintaining laboratory operations at cGMP standards to ensure quality, safety, and regulatory compliance,
• Controlling stock related to Biological,
• Monitoring equipment and maintenance of Biological equipment,
• Contributing to drafting, updating, proof reading and editing of procedures related to Biological testing,
• Sampling of utilities, routine, and non-routine,
• Biological testing, routine, and non-routine (including utilities testing, raw material, in process, final product testing and stability).
• Reviewing of laboratory raw data related to Biological testing,
• Compiling laboratory reports related to Biological testing,
• Completing trend analysis templates as laboratory results are obtained from a Biological perspective,
• Participate in departmental audits and implement corrective actions where relevant.
• Actively involved with OOS and/or OOT investigation related to Biological testing (internal or external testing) and ensuring that OOS and/or OOT

investigations are completed on time, and to the correct standard,

• Ensure that DMS queries are attended to within a reasonable time as the System Owner, and escalated to Laboratory Supervisors and

management,

• Ensuring timely and effective communication by escalating quality issues to the appropriate levels of management, including DMS
• Excursions
• Assisting with implementation of the Containment Control Strategy (CCS) for the site.

Technical Competencies required to perform this aspect of the role:

• Computer Literacy and a good working knowledge of Microsoft office,
• Basic understanding of legislation relating to documentation
• Basic understanding of legislation relating to reporting requirements
• Detailed knowledge of pharmaceutical industry standards and guidelines in cGMP, Quality and Laboratory Management.
• Laboratory skills and techniques
• Report writing skills,
• Quality Management Systems
• Environmental, Health & Safety management.
• Statistical trending, data analysis & reporting,
• Coaching & mentoring of peers.

Supporting 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.
• Establish and maintain a state of control related to quality management within the department.
• Ensuring audit readiness within own role through closing out audit findings timeously
• Ensure Deviations, Change Controls, CAPAs 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
• Coaching & mentoring peers & staff

Generic Competencies required to perform this role:

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

Quality Management

• Building own, team and site’s GMP Knowledge and Compliance
• Participate in building quality objectives and provide ongoing metrics that directly support the achievement of such objectives.
• Participate in building a sustainable Quality Culture on site and proactive mitigate risks that may negatively impact quality or escalate these appropriately.
• Establish and maintain a state of control related to quality management within the department
• Ensuring that the department is audit ready through closing out audit findings timeously
• Ensure Deviations, Change Controls, CAPAs are handled effectively
• Advocate continuous improvement within own department as well as cross functionally

Technical Competencies required to perform this aspect of the role:

• cGMP vaccine manufacturing