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 writing of departmental procedures required for qualification.
- Represent Validation department during internal and 3rd party audits wrt process validation requirements by interacting with auditors.
- Ensures compliance in accordance with the Medicines and Related Substances Act 101 of 1965 and the Pharmacy Act 53 of 1974, and the organization’s policies, procedures, and other applicable laws.
- Identify and report any potential risks associated to the process validation activities and address all QMS actions.
- Continuously build and support a sound quality assurance culture aligned to cGMP within the company.