Location: Johannesburg
Job Posting Title: Senior Officer, Validation - IT, Healthcare
Time Type: Full Time
Job Related Requirements:
- 3 - 5 years in Software testing experience and/or 3 - 5 years experience in Delta All facets.
- Validation / Pharmaceutical or Equivalent qualification or related field recommended.
- Proven industry experience in validation ideally within a GWP distribution environment recommended.
- Knowledge and practical experience with equipment qualification (RA, URS, DQ, IQ, OQ, PQ, PR) protocol and report compilation recommended.
- Strong troubleshooting, mathematical, analytical, and problem-solving skills.
- Knowledge of industry best practices (e.g., GAMP, ISPE) across computerized systems recommended.
- Excellent report writing and data interpretation skills.
Computer Literacy Level:
- Advanced Microsoft Office knowledge
Main Purpose of the Role:
- Computer system validation
- Risk analysis
- Effectiveness check reviews
- CAPA reviews
Duties and Responsibilities:
- Maintain validation and calibration schedules, liaising with contractors.
- Prepare validation documentation meeting 21 CFR Part 11, WHO, SAHPRA requirements; Plans, Protocols, Reports.
- Ensure validation exercises are conducted timely and in compliance with GWP and project milestones.
- Participate in change control assessments and project meetings to maintain compliance of equipment.
- Participate in audits as necessary.
- Focus on computer, facility, and transport validation studies, maintaining GWP compliance.
- Manage site validation documentation and complete risk assessments.
- Prepare and review departmental SOPs.
- Collaborate with QA, Operations, Maintenance, and other departments to resolve audit findings.
Note: This job posting is active. The original content about DSV's company overview and disclaimers has been omitted for focus and clarity.