Senior Officer, Validation, Healthcare

7 days ago

Johannesburg, South Africa DSV Full time

**DSV - Global transport and logistics**

Location: Johannesburg
Job Posting Title: Senior Officer, Validation, Healthcare
Time Type: Full Time

**Job Related Requirements**:

- 5 years experience in Validation required
- Validation /Pharmaceutical or Equivalent qualification or related field recommended
- Proven industry experience in validation ideally within a GWP distribution environment.
- Demonstrated knowledge of industry best practices (e.g. GAMP and ISPE) across a range of computerised systems
- A working knowledge and practical experience with equipment qualification (RA, URS, DQ, IQ, OQ, PQ and PR) protocol and report compilation.
- Knowledge of temperature/humidity mapping, data processing and reporting.
- Strong troubleshooting, mathematical, analytical and problem-solving skills.
- Excellent report writing and data interpretation.
- Laboratory validation activities will be an added advantage.

**Computer Literacy Level**:

- Advanced Microsoft Office knowledge
- Knowledge of Delta advantageous

**Main Purpose of the Role**:

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

- Facility Validation
- Transport Validation
- Risk Analysis
- Effectivenes check reviews
- CAPA Reviews
- Computer system Validation

**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.

**DSV - Global transport and logistics**

DSV is one of the very best performing companies in the transport and logistics industry. 75,000 employees in more than 90 countries work passionately to deliver great customer experiences and high-quality services - as part of the operation or in a variety of supporting roles. If you have drive and talent and enjoy responsibility, we’ll give you the support you need to explore your potential and forward your career.

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