Data Integrity Officer

BI VAC Cape Town, Western Cape, South Africa Data Integrity Officer 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, analyse 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 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 If you do not receive a response from us within three weeks of submitting your application, please understand that your application was not successful. We believe in the magic of diversity within teams and to achieve this, we do apply Employment Equity principles during our selection process where this is necessary to achieve such diversity. Dear Applicant, we appreciate your interest in joining our organization. It is imperative for us that you understand how we handle your information. We are committed to ensuring the security and confidentiality of the information you provide. Your personal details will be collected for the sole purpose of the application process and will be used strictly for that purpose. By applying, you acknowledge and consent to the collection, use, and protection of your personal information in accordance with our privacy policy. If you have any inquiries or concerns, our Human Capital department is available to provide clarification. We look forward to reviewing your application. #J-18808-Ljbffr