Data Integrity LeadBiovac • Cape Town, ZA
Data Integrity Lead
Biovac • Cape Town, ZA
12 days ago
Job descriptionDegree or Diploma in Computer Science, Information Technology, Information Systems, Engineering, Automation or related discipline. 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. 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. Research / Data Analysis jobs
Job title : Data Integrity Lead
Job Location : Western Cape, Cape Town
Deadline : December 31, 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 Lead to join a goal-oriented team.
QUALIFICATIONS NEEDED :
NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE :
KEY DUTIES & RESPONSIBILITIES OF THE ROLE :
Core Technical Delivery :
Application Deadline : 29 November 2025
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Data Lead • Cape Town, ZA
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