Job Description

Qualifications Required:

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

Necessary Experience and Industry Accreditation

• 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.
• Good Engineering Practice and understanding of ISPE guide.

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.
• Ensure execution of routine qualification activities i.e. Equipment / Utility / Facility, Systems, CSV and Data Integrity.
• Review and approves protocols and reports for all qualification activities based on company standards/guidelines, procedures, and
• Industry current practices.
• Reporting on key operations, critical numbers and key performance indicators that impacts the sections 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 sections transition into commercial operations and mind-set as well as managing efficiencies, reducing wastage and contributing to overall profitability.
• Assist in Process Development activities including Process Validation, Cleaning Validation and Cold Chain.
• Participate in Process Automation and Data Management activities including Data Integrity and CSV.
• Ensure execution of qualification processes: FAT, Commissioning, SAT, DQ, CIA, SLIA, IQ, OQ, PQ and PRQ as per defined timelines and cGMP and report timeously on qualification 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 CAPAs 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 qualification 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 organizations policies, procedures, and other applicable laws.
• Identify and report any potential risks associated to the qualification activities and address all QMS actions.
• Continuously build and support a sound quality assurance culture aligned to cGMP within the company.

ABC Worldwide