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Data Integrity Officer
Data Integrity OfficerBiovac • Cape Town, ZA
Data Integrity Officer

Data Integrity Officer

Biovac • Cape Town, ZA
13 days ago
Job description

Job title : Data Integrity Officer

Job Location : Western Cape, Cape Town

Deadline : December 03, 2025

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  • 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 Data Integrity Officer to join a goal-oriented team.

QUALIFICATIONS NEEDED :

  • Degree or Diploma in Computer Science, Information Technology, Information Systems, Engineering, Automation or related discipline.
  • NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE :

  • Experience in a pharmaceutical or biotechnology environment with a focus on qualification and validation specifically CSV, data integrity, quality assurance, or regulatory compliance.
  • Understanding of regulatory requirements and guidelines related to CSV and data integrity.
  • Analytical skills and attention to detail, with the ability to identify issues, analyze root causes, and implement effective solutions.
  • Communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and communicate complex concepts to diverse audiences.
  • KEY DUTIES & RESPONSIBILITIES OF THE ROLE :

    Core Technical Delivery :

  • Liaising with internal and external service providers.
  • Implement general DI and CSV activities and the associated strategy.
  • Execute all DI and CSV activities according to the defined schedules.
  • Follow CSV and DI qualification strategies as outlined and be the DI Lead.
  • Execute CSV processes : DQ, Impact Assessment, IQ and OQ as per defined timelines in accordance to GAMP guidance.
  • Assist system owners with identifying data maintenance requirements.
  • Participate in troubleshooting discussions to investigate a wide range of challenges which requires creative thinking.
  • Maintaining CSV and DI master plan / validation plan, schedules and other related documentation.
  • Communicate DI and CSV status to the DI Lead on a regular basis.
  • Escalate any delays / issues / changes experienced during DI and CSV task execution.
  • Escalate with departments related to DI and CSV activity planning and allocated timelines.
  • Provide critical information to staff from other departments related to the required content of procedures.
  • Identify quality risks within CSV and DI and initiate risk management where required, e.g. to support investigation decisions.
  • Partake in problems and new initiatives to ensure that a science & risk-based approach is adoptive to support.
  • Ensure that SOPs, Plans and documents are up to date with the latest pharmaceutical and best practice guidelines.
  • Ensure Deviations, Incidents, Change Controls, CAPAs, audit findings, RAs related to DI and CSV are handled effectively.
  • Ensure that the DI and CSV schedule are in place, communicated, updated and delivered on according to defined timelines.
  • Support the Data Integrity Lead with DI and CSV strategy and associated department goals setting.
  • Partake in activities performed by external stakeholders according to defined schedules.
  • Engage in investigations linked to DI and CSV activities.
  • Application Deadline : 21 November 2025

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    Data Officer • Cape Town, ZA

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