Senior Officer, Validation - IT, Healthcare at DSV

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:

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

• 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.