MAIN PURPOSE OF THE ROLE
Manage validation team of 4 staff.
Duties will be varied however the key duties and responsibilities are as follows:
Computer system validation
Equipment validation
Warehouse and vehicle mapping
Risk Analysis
Effectivenes check reviews
CAPA Reviews
Tertiary Qualification
Matric
Validation /Pharmaceutical or Equivilent qualification or related field recomended (Essential)
Additional Computer Skills
Delta (Advantage)
Computer Literacy – Advanced
Electives
Any validation courses completed
Job-related Requirements
3 Years Experience
Validation /Pharmaceutical or Equivilent qualification or related field recomended
Proven industry experience in validation, ideally within a GWP distribution environment recomended.
A working knowledge and practical experience with equipment, IT systems, warehouse and vehicle mapping (RA, URS, DQ, IQ, OQ, PQ), protocol and report compilation recomended.
Advanced working knowledge of Microsoft Office products (Excel, Outlook, PowerPoint and Word)
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.
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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