Manager, Validation and Accreditation, Healthcare at DSV

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.