Validation Lead: Qualification

2 months ago

Cape Town, South Africa ABC Worldwide Full time

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 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.
  • 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 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 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 organization’s 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.

 

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