Validation Lead: Process - Pharmaceutical

Qualifications required:

• Degree or diploma in Engineering / Natural Sciences / Microbiology or equivalent.

Necessary Experience and Industry Accreditation/Knowledge

• At least 5 years’ experience in pharmaceutical/ biotech manufacturing industry.
• At least 1 to 2 years’ experience at junior to Senior Management level.
• Experience in quality management systems within a cGMP facility.

Key Duties and Responsibilities

• Management and mentorship of Senior Validation Scientists, Validation Scientists and Validation Interns.
• Ensuring that Validation requirements are achieved at the required quality and regulatory levels (Company, SAHPRA, WHO, pharmacopoeia) and within the agreed timeframes.
• Conduct section planning and execute activities within own scope of accountability.
• Ensure adequate capacity planning and performance delivery in line with strategic, tactical and operational plans.
• Role profiling, goal setting and performance management of Validation staff within the section.
• Review and/or update high level validation and qualification guidance documents, such as VMP, VPs, SOPs.
• Attend and participate on technical and projects strategic meetings/discussions involving internal and external stakeholders.
• Assist in execution of routine qualification activities i.e. Equipment / Utility / Facility, Systems, CSV and Data Integrity.
• Review and approves protocols and reports for all process validation activities based on company standards/guidelines, procedures, and
• Industry current practices.
• Reporting on key operations, critical numbers and key performance indicators that impacts the section’s short, medium- and long-term objectives.
• Conduct effective and comprehensive costing, budgeting and expense management for own section, taking all overlapping site activities into consideration.
• Lead own section’s transition into commercial operations and mind-set as well as managing efficiencies, reducing wastage and contributing to overall profitability.
• Ensure execution of process validation activities including Process Development, Process Validation, Cleaning Validation, Cold Chain and Ongoing Process Verification.
• Participate in Process Automation and Data Management activities including Data Integrity and CSV.
• Report timeously on validation progress and status to the Validation Manager.
• Ensure and or assist system/ equipment owners with identifying maintenance and calibration requirements.
• Ensure relevant OOS and OOT investigation non-conformances/ deviations, change controls and CAPA’s are initiated and completed.
• Tracking and expediting the review and sign-off of validation documentation.
• Writing / guiding the ...
  
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