Senior Officer, Validation - It, Healthcare

Dsv; Gauteng; On-site; ZAR 500,000 - 800,000; Full time

Job summary

A leading logistics company, DSV, is seeking a Software Validation Specialist to ensure compliance with industry regulations and standards. The role involves effective maintenance of validation schedules, preparing required documentation, and collaborating with various departments to address audit findings, making it essential for impactful operations within the organization.

Qualifications

• 3-5 years in Software testing experience.
• 3-5 years in Delta All facets.
• Proven industry experience in validation.

Responsibilities

• Maintain validation and calibration schedules.
• Prepare validation documentation for regulatory standards.
• Focus on validation studies for computer systems and facilities.

Skills

Troubleshooting

Analytical skills

Problem-solving

Report writing

Data interpretation

Advanced Microsoft Office skills

Education

Pharmaceutical qualification

Job description

Minimum Requirements : 3 – 5 years in Software testing experience and/or 3 - 5 years experience in Delta All facets. Validation / Pharmaceutical or related qualification recommended. Proven industry experience in validation, ideally within a GWP distribution environment. Practical experience with equipment qualification (RA, URS, DQ, IQ, OQ, PQ, PR) protocol and report compilation. Strong troubleshooting, mathematical, analytical, and problem-solving skills. Knowledge of industry best practices (e.g., GAMP, ISPE) across computerised systems. Excellent report writing and data interpretation skills. Advanced Microsoft Office skills.

Main Purpose of the Role : Computer system validation. Effectiveness check reviews. CAPA reviews.

Duties and Responsibilities :

1. Maintain validation and calibration schedules, liaising with contractors.
2. Prepare validation documentation to meet standards such as 21 CFR Part 11, WHO, SAHPRA, including plans, protocols, and reports.
3. Ensure validation exercises are conducted timely and in compliance with GWP and project milestones.
4. Participate in Change Control assessments and project meetings to maintain equipment compliance.
5. Participate in corporate, regulatory, and internal audits as needed.
6. Focus on validation studies for computer systems, facilities, and transport, maintaining GWP compliance.
7. Manage validation documentation and perform risk assessments.
8. Prepare and review departmental SOPs.
9. Collaborate with QA, Operations, Maintenance, and other departments to resolve audit findings.

About DSV : DSV is a global leader in transport and logistics, committed to innovation, digitalization, and growth. With nearly , colleagues across over 90 countries, we strive to provide excellent services and meet our customers' needs. We value new talent, diverse perspectives, and ambition. At DSV, performance and collaboration are key. We embrace inclusivity, respect cultural differences, and foster a respectful workplace. Join us to make an impact, gain trust, and advance your career in a forward-thinking company.