The Biovac Institute requires a Qualification Scientist to contribute to its mission of establishing local biological and vaccine manufacturing capability at its Cape Town based site. Being the only one of its kind in South Africa, Biovac strives to respond to the vaccine needs of the developing countries, specifically South Africa and Sub Saharan Africa. 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 incumbent will report to the Qualification Section Head.

Key Areas of Responsibility:
•Plan and perform Qualification activities of Biotechnology API equipment, facility and the associated periodic checking at the required quality levels (TBI, MCC and WHO) and within the agreed times.
•Ensures undisrupted, punctual and safe operation of qualified equipment and validated processes.
•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.
•Ensures compliance in accordance with (Medicines and Related Substances Act 101 of 1965, Pharmacy Act 53 of 1974) and the organizations policies, procedures and other applicable laws.
•Participation in quality audits and support to qualification / validation teams.
•Ensure that the qualification of Facilities and process equipment’s like, COP / SIP systems, Autoclaves, tunnels, washers, filling machine, Filtration systems, computer software and hardware, procedures and test methods are up to date and meet internationally accepted standards and GMP expectations.
•Service providers that are contracted to provide the correct testing services.
•Ensure that stakeholders are appropriately informed or trained.
•Ensure that customers and stakeholders are informed of and engaged in planned activities.
•Ensure all allocated activities are performed ahead of due date.
•Practice effectively and creatively in planning of implementation objectives and timelines with stakeholders and managers.
•Efficient implementation, report generation and resolution of issues raised.
•Ensure that a qualified or validated state is maintained and that the proof of this is fully documented.
•Building GMP knowledge and compliance
•Building Quality Culture
•Establishing and maintaining a state of Control
•Driving innovation and Continuous improvement
•Driving Quality Risk Management
•Ensuring that area of responsibility is audit ready; closing audit findings
•Managing Deviations, Change Controls, CAPAs
•Drive the quality objectives.


Communication:
•Ensure a timely and effective communication.
•Escalate quality issues to the appropriate levels of management.

Generic Competencies:
•Good coordination skills
•Skills Transfer ability
•Attention to detail
•Good verbal Communication
•Relationship management
•Planning and execution
•Self – Management
•Attention to detail
•Ability to drive and execute to completion
•Good Written and verbal communication
•Coordination ability
•Project planning, implementation, execution and close out skills.
•Flexibility and adaptability in responding to change
•Verbal and written Communication Ability

Technical Competencies:
•Knowledge of pharmaceutical industry standards and guidelines in GMP
•Good Understanding of Quality Systems, process and documentation
•Proficient in Microsoft Office
•Technical report writing
•cGMP vaccine manufacturing – quality and regulatory compliance knowledge, i.e. MCC and WHO
•Quality Management system
Education and experience required:
•Degree or diploma in electronics & computer Engineering or related subject or equivalent extensive experience
•Minimum of 5 years’ experience in computer validation in pharmaceutical industry
•Minimum 3 years’ manufacturing / maintenance experience in e.g. vaccine / biotech / parenteral pharmaceutical industry or equivalent would be advantageous.
•Quality & regulatory compliance knowledge, i.e. MCC and WHO would be an advantage.
•Experience in having faced successfully local quality audits would be an advantage.
•Qualifying, validating and re-assessing pharmaceutical facilities, utilities, equipment, computer systems (PLC’s, SCADA’s, DCS) systems or processes.
•Knowledge of the standards and test methods for such functional testing and experience of testing Grade A and B clean room environments would be highly advantageous.
•Generation and execution of qualification or validation protocols. Involvement in formal Risk Management processes

All positions will be filled in accordance with our Employment Equity policy as The Biovac Institute is committed to the pursuit of excellence, diversity and redress. If you are interested in applying for this position, kindly forward your application onto by 30 November 2017
Kindly note that by submitting your application for this career opportunity you agree that Biovac may use your application for the purpose of the recruitment and selection of the said position and this information may be shared with the relevant stakeholders in the business