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Senior Officer, Validation

2 weeks ago

Sandton, South Africa DSV Full time

If you are a current DSV employee and interested in a position in another country, please contact your Human Resource representative to discuss the process and requirements of applying.

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.
- A working knowledge and practical experience with equipment qualification (RA, URS, DQ, IQ, OQ, PQ and PR) protocol and report compilation recommended.
- Strong troubleshooting, mathematical, analytical and problem-solving skills.
- Knowledge of industry best practices (e.g. GAMP and ISPE) across a range of computerised systems recommended.
- Excellent report writing and data interpretation.

**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**:

- Duties will be varied however the key duties and responsibilities are as follows:

- You will be responsible for maintaining validation and calibration schedules while liaising with contractors.
- To prepare validation documentation to meet 21 CFR Part 11, WHO, SAHPRA, etc; Plans, Protocols and Reports
- To ensure assigned validation exercises are conducted in a timely manner and in compliance with GWP and project milestones.
- To participate in Change Control assessments and project meetings to ensure the compliant status of affected equipment is not compromised.
- To participate in corporate, regulatory and internal audits as necessary.
- Focus on Computer, facility and transport validation studies and maintain GWP compliance at all times.
- Managing of site validation documentation and completion of validation risk assessments.
- Preparation and Review of Departmental SOPs.
- Work with QA, Operations, Maintenance and other departments to resolve audit findings.

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