Data Integrity Lead - CSV & Pharma Compliance

Biovac; Wes-Kaap; On-site; ZAR 200 000 - 300 000; Full time

Job summary

A leading vaccine manufacturer in South Africa is seeking a Data Integrity Lead to enhance data integrity practices and compliance. This role requires 3-5 years of experience in pharmaceutical or biotechnology environments, focusing on qualification and validation processes. Strong analytical skills and understanding of regulatory guidelines are essential. Join a passionate team dedicated to quality assurance and innovation in vaccine manufacturing.

Qualifications

• 3-5 years of experience in a pharmaceutical or biotechnology environment focused on data integrity.
• Strong understanding of regulatory requirements (e.g., FDA CFR Part 11).
• Ability to collaborate with cross-functional teams.

Responsibilities

• Liaise with internal and external service providers.
• Define and execute DI and CSV activities according to schedules.
• Lead troubleshooting discussions for diverse challenges.

Skills

Regulatory compliance understanding

Excellent analytical skills

Strong communication skills

Education

Degree or Diploma in Computer Science, Information Technology, Information Systems, Engineering, Automation or related discipline

Tools

Electronic document management systems (EDMS)

Laboratory information management systems (LIMS)

Job description

A leading vaccine manufacturer in South Africa is seeking a Data Integrity Lead to enhance data integrity practices and compliance. This role requires 3-5 years of experience in pharmaceutical or biotechnology environments, focusing on qualification and validation processes. Strong analytical skills and understanding of regulatory guidelines are essential. Join a passionate team dedicated to quality assurance and innovation in vaccine manufacturing.