Data Integrity Officer 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 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