Data Integrity Lead 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 Lead 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:

• 3-5 years of experience in a pharmaceutical or biotechnology environment with a focus on qualification and validation specifically CSV, data integrity, quality assurance, or regulatory compliance.
• Strong understanding of regulatory requirements and guidelines related to CSV and data integrity (e.g., FDA CFR Part 11, Annex 11, GAMP).
• Experience with electronic document management systems (EDMS), laboratory information management systems (LIMS), and other electronic data capture systems.
• Excellent analytical skills and attention to detail, with the ability to identify issues, analyse root causes, and implement effective solutions.
• Strong 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.
• Define general DI and CSV activities and the associated strategy.
• Ensure execution of all DI and CSV activities according to the defined schedules.
• Define CSV and DI qualification approaches to new equipment for site.
• Ensure execution of Qualification processes: DQ, Impact Assessment, IQ and OQ as defined timelines in accordance with GAMP guidance.
• Assist system owners with identifying information maintenance requirements.
• Participate in and lead troubleshooting discussions to investigate a wide range of challenges which require creative thinking.
• General administration such as updating of the master plan / validation plan, maintaining schedules, standard referencing of documentation.
• Exercise significant technical discretion in design, execution, and interpretation, and pursues new studies as a result of experimental outcomes.
• Communicate DI and CSV status to the business on a regular basis.
• Communicate any delays/ issues/ changes experienced during DI and CSV task execution.
• Communicate with departments related to DI and CSV activity planning and allocated timelines.
• Provide guidance to staff from other departments related to the required content of procedures.
• Identify quality risks in the section and initiate risk management where required, e.g. to support investigation decisions.
• Provides scientific input into 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 Validation Manager with DI and CSV strategy and associated department goals setting.
• Provide guidance and oversight for activities performed by external stakeholders according to defined schedules.
• Lead significant investigations linked to DI and CSV activities.

Application Deadline: 29 November 2025