Biologics Process Validation Leader

2 days ago


Dubai, Dubai, United Arab Emirates GSK Full time
Biologics Process Validation Leader

We are seeking a highly skilled Biologics Process Validation Leader to join our team at GSK. As a key member of our team, you will be responsible for leading the technical aspects of the product lifecycle, including technical risk assessments, product control strategies, bench, pilot, and commercial scale validation studies, QbD, PPQ, CPV, and change control.

Key Responsibilities:
  • Lead technical aspects of product lifecycle, including technical risk assessments and product control strategies.
  • Develop and implement validation strategies for bench, pilot, and commercial scale processes.
  • Collaborate with cross-functional teams to deliver results to agreed timelines.
  • Ensure compliance with current and emerging regulatory strategies, including Quality by Design, GMP for 21st century, ICH Q7, Q8, Q9, Q10, and Product Lifecycle Management.
  • Develop and maintain knowledge of regulatory requirements in the industry and drug development.
Requirements:
  • BSc in Scientific Discipline.
  • Minimum 5 years' demonstrated experience in the Pharmaceutical Industry in leading technical aspects of the product lifecycle.
  • Excellent problem-solving skills and ability to think and work creatively.
  • Demonstrated knowledge of Quality by Design and risk management approaches.
  • Ability to support due diligence.

We offer a dynamic and challenging work environment, with opportunities for professional growth and development. If you are a motivated and experienced professional looking for a new challenge, please submit your application.



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