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.