Overview

QA & Validation Specialist Jobs in Cape Town, South Africa at Biovac

BIOVAC is one of the leading sterile vaccine manufacturers rooted in Africa, with our core purpose being to “protect life”. We are looking to hire a dynamic, passionate, confident, proactive, and meticulous QA & Validation Specialist to join a goal-oriented team.

QUALIFICATIONS NEEDED:

  • Degree or diploma in Microbiology/ Science/ Pharmacy/ Engineering or equivalent.

NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE:

  • At least 3 years’ experience in validation, quality assurance and/or technical transfer in a pharmaceutical/ biotech manufacturing industry.
  • At least 3 years’ experience in quality management systems and/or operations within a cGMP facility.
  • Experience in participating in the planning and execution of qualifications and validation of new/updated facilities, equipment, utilities and processes.
  • Experience with the development/ generation of qualification or validation protocols.
  • Knowledge of Pharmaceutical Quality Systems.
  • Knowledge of Risk Management Systems.

KEY DUTIES & RESPONSIBILITIES OF THE ROLE:

Core Technical Delivery:

  • Actively engage in projects and technical projects, serving as a Quality Subject Matter Expert (SME) as outlined by the QA & Validation Technical Lead.
  • Collaborate with the QA & Validation Technical Lead to define deliverables for project and technical activities.
  • Collaborate with Tech Transfer and Project department on Quality, Qualification and Validation requirements and decisions.
  • Participate in projects as needed, supporting the timely and quality delivery of project objectives.
  • Liaising with internal stakeholders (Tech Transfer, Projects, QC, Production, Engineering, QA & Validation).
  • Participate in Tech Transfer and project meetings & decision making in qualification and QA approaches as subject matter experts as outlined by the QA & Validation Technical Lead.
  • Manage, drive and support Change Management, Risk Management and Deviation practices in all allocated projects.
  • Participate in Process Development activities.
  • Developing, improving, and maintaining validation plans, templates & protocols in line with current and future projects & tech transfer as outlined by the QA & Validation Technical Lead.
  • Developing, improving, and maintaining quality plans & trackers as in line with current and future projects & tech transfer as outlined by the QA & Validation Technical Lead.
  • Execution of qualifications and validation processes.
  • Driving quality assurance processes in project & tech transfer activities.
  • Provide regular updates to the QA & Validation Technical Lead.
  • Provide mentorship to QA & Validation officers where required.
  • Review and Approve PQS documents and records in tech transfer projects with QA responsibilities.
  • Ensure audit readiness within own role by promptly addressing and closing out audit findings.
  • Participates in troubleshooting a wide range of problems & designing of systems which requires creative thinking. Exercises significant technical discretion in design, execution, and interpretation, and pursues new validation/qualifications studies as a result of experimental outcomes.
  • Communicate status and any delays/ issues/ changes experienced during validation and quality activities.
  • Communicate with departments regarding validation planning and time needed on validation activities.
  • Provide guidance to staff from other departments regarding the required quality of procedures.
  • Manage internal customer relations and communication.
  • Participation in execution revokes all approval authority.

Validation & qualification:

  • Develop and continuously improve validation plans and protocols based on regulatory requirements, guidelines, experience and sound science.
  • Compilation, execution and review of protocols and reports.
  • Validation Approval on protocols and reports.
  • Regularly communicate the status of project activities related to qualification and validation to the business.
  • Resolve any delays, issues, or changes experienced during project qualification and validation task execution.
  • Communicate with departments regarding qualification and validation project planning and associated timelines.
  • Provide scientific input into problems and new initiatives, ensuring a science and risk-based approach is…

Title: QA & Validation Specialist

Company: Biovac

Location: Cape Town, South Africa

Category:

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