Website The Biovac Institute
The Biovac Institute requires three Quality Control Analysts to contribute to its mission of establishing and maintaining effective value creation for its biological and vaccine partners and stakeholders within its current and future commercial footprint.
Being the only one of its kind in South Africa, Biovac strives to respond to the sterile injectable needs, particularly related to vaccines and other biologicals, South Africa, Sub Saharan Africa and other developing countries.
This is a particularly exciting time for the company as it continues to grow, strengthen and build on its success and further develop its capabilities, products, services and market diversification.
The successful incumbents will report to the QC Chemistry Supervisors.
Summary of role
- 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 organisational departments and/or teams.
- Ensuring compliance in accordance with the Medicines and Related Substances Act 101 of 1965 and Pharmacy Act 53 of 1974, and the organization’s policies, procedures and other applicable laws.
- Participation in quality audits and support to validation teams.
- Effective implementation / maintenance of quality systems & safety systems.
- 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.
- Ordering and stock control.
- Participation in quality audits.
- Equipment monitoring and maintenance.
- Contributing to drafting, updating, proofreading and editing of procedures.
- Sample receipt and logging of samples.
- Routine testing (incl. testing of utilities, raw materials, in-process samples, product and stability samples).
- Compiling laboratory reports.
- Completing trend analysis templates as laboratory results are obtained.
- Diploma or degree in Chemistry, Analytical Chemistry, Biochemistry or related subject.
Knowledge & Experience Required
- General chemical knowledge, testing methods and technologies.
- Knowledge of current GMP
- Experience in a pharmaceutical QC laboratory would be an advantage.
- Must demonstrate competency in laboratory skills, including documentation.
- May require some occasional overtime, shift and/or weekend coverage to accommodate schedules and/or project timelines
- General chemical knowledge, testing methods and technologies
- Knowledge of current GMP
- Record/documentation management
- Computer literacy
- Basic Laboratory Skills and Techniques
- Good Time Management
- Analytical thinking.
- Communication skills (verbal and written).
- Problem solving.
- Service orientation
- Compliance orientation
- Attention to detail
- Positive team contribution
- In support of Biovac’s Vision, Mission, and Values :Anticipate & Innovate
- Own, deliver and enjoy
- Achieve service excellence
- Preserve & sustain
If you are interested in applying for this opportunity then forward your application to email@example.com by close of business on the 30 June 2018.
Disclaimer: Biovac supports employment equity principles and for this reason, all vacancies are filled in accordance with our diversity management strategy and equity plans. Furthermore, by submitting your application you agree that Biovac may use your information and share relevant information with our recruitment and selection stakeholders involved in this process.