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, andIndustry 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.
