Data Integrity Lead

Cape Town - South Africa

Monthly Salary: Not Disclosed

Posted on: 19 hours ago

Vacancies: 1 Vacancy

Job Summary

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

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.

Disclaimer:

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.

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 Comput...