Senior Validation Scientist

Website The Biovac Institute

The Biovac Institute requires a Senior Validation Scientist 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 incumbent will report to the Section Head: Qualification.

Summary of role

  • Plan and coordinate qualification activities according to Validation Plans and/or Project plans.
  • Prepare, review or coordinate qualification protocols.
  • Coordinate with user department and follow up on writing of URS.
  • Ensure execution of FAT and SAT activities where appropriate.
  • Execute or ensure executing of qualification processes: DQ, CIA, SLIA, IQ, OQ, PQ and PT as per defined timelines and according to cGMP.
  • Review and approve executed qualification protocol reports and other relevant documents pertaining to specific qualification requirements.
  • Review qualification related documents for compliance to the Equipment/ Utility/ Facility qualification requirements and good documentation practices.
  • Investigate/ troubleshoot qualification problems.
  • Notify relevant department manager regarding issues of non-conformance and recommends corrective actions.
  • Open Vendor certification for external companies to be used for qualification activities.
  • Ensure that Service Level Agreements are in place where applicable when external companies are used for qualification activities.
  • Provide coaching/mentoring on Equipment/ Utility/ Facility qualification topics, as required, to the team members
  • Prepare and review changes to the SOP’s pertaining to Equipment/ Utility/ Facility qualification.
  • Ensures that procedures, work instructions, standards maintenance documents or master documents describe critical parameters or ranges determined in Equipment/ Utility/ Facility qualification studies.
  • Review and assess changes and their impact to the qualification status following appropriate change control procedures.
  • Provide technical support in resolving Equipment/ Utility/ Facility qualification related deviations.
  • Manage internal customer relations and communications.
  • Participate in inspections, investigations and risk management exercises.
  • Maintain documentation records of qualification of equipment, systems and utilities.
  • 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 Deviations, Change Controls, CAPAs are handled effectively
  • Advocate continuous improvement
  • Plan and perform qualification of equipment and the associated periodic checking at the required quality levels (Biovac, MCC and WHO) and within the agreed timelines.
  • Ensure undisrupted, punctual and safe operation of qualified equipment and validated processes.
  • Ensure that the activities in the Quality Assurance Department are achieved at the required quality levels (SA GMP, PIC/S and WHO).
  • Participating in project teams and supporting other relevant organizational departments.
  • Mentoring and coaching of qualification team
  • 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 Deviations, Change Controls, CAPAs are handled effectively
  • Advocate continuous improvement

KNOWLEDGE & CAPABILITY REQUIREMENTS TO SUCCEED IN THIS ROLE:

Preferred

  • Knowledge and experience in quality management systems within a cGMP facility.
  • Knowledge of the standards and test methods for such functional testing and experience of testing Grade A and B clean room environments.
  • Experience in having faced successful local quality audits.
  • Knowledge of Pharmaceutical related legislation

Required

  • At least 6 years’ experience within vaccine/ biotech/ parenteral pharmaceutical industry or within a similar position.
  • Experience in quality management systems within a cGMP facility.
  • Qualifying, validating and re-assessing pharmaceutical facilities utilities, equipment, computer systems and processes.
  • Experience within the development/ generation of qualification or validation protocols

Qualifications:

Required

  • Diploma or degree in Engineering/ Biotechnology/ Chemistry/ Biochemistry or equivalent.
  • Recognition is given to Prior Learning and practical experience

Experience

Required: Preferred:
§  At least 6 years’ experience within vaccine/ biotech/ parenteral pharmaceutical industry or within a similar position.

§  Experience in quality management systems within a cGMP facility.

§  Qualifying, validating and re-assessing pharmaceutical facilities utilities, equipment, computer systems and processes.

§  Experience within the development/ generation of qualification or validation protocols

§  Knowledge and experience in quality management systems within a cGMP facility.

§  Knowledge of the standards and test methods for such functional testing and experience of testing Grade A and B clean room environments.

§  Experience in having faced successful local quality audits.

§  Knowledge of Pharmaceutical related legislation

Other Requirements:

  • Own reliable transport, conducting frequent road and air travel to conferences, business meetings and industry events, ability to work a flexible schedule in line with business and industry activities.

Competencies:

Technical Generic
 

§  Excellent understanding and working knowledge of Quality Operations and systems.

§  Detailed knowledge of pharmaceutical industry standards and guidelines in GMP, Quality and Laboratory Management

§  Pharmacopoeia methods, standards, guidelines and relevant agency recommendations on QC testing.

§  Documentation Management

§  Inventory Management

§  Environmental, Health & Safety Management

§  Statistical Trending & Data Analysis

§  cGMP knowledge

§  Total Quality Management & Quality Management Systems

§  Data development, trending & reporting

 

 

§  Planning, Organising, execution and monitoring

§  Creative problem solving skills

§  Internal stakeholder management

§  Action & Results Oriented

§  Assertive & Resilient

§  Ability to multi task

§  Influencing skills

§  Proactive

§  Clear, timely and effective communication skills both verbally and in writing

 

If you are interested in applying for this opportunity then forward your application to recruitment@biovac.co.za  on or before 31 May 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

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