QC Analyst: Biochemistry

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,
• Compl…