Biologics Process Validation Director
3 weeks ago
We are seeking a highly skilled Biologics Process Validation Leader to join our team at GSK. As a key member of our organization, 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, Quality by Design, PPQ, CPV, and change control.
Key Responsibilities- Technical Leadership: Provide technical guidance and oversight to ensure the successful execution of process validation activities, including technical risk assessments, product control strategies, and validation studies.
- Process Validation Expertise: Develop and implement process validation strategies, including Quality by Design, PPQ, CPV, and change control, to ensure compliance with regulatory requirements.
- Collaboration and Communication: Work closely with cross-functional teams, including quality, manufacturing, and regulatory, to ensure seamless execution of process validation activities and effective communication of results.
- Regulatory Compliance: Ensure compliance with current and emerging regulatory strategies, including GMP for the 21st century, ICH Q7, Q8, Q9, Q10, and Quality by Design.
- Problem-Solving and Creativity: Utilize excellent problem-solving skills and creative thinking to address complex technical challenges and develop innovative solutions.
- Knowledge Management: Develop and maintain a broad and integrated knowledge of all aspects of biopharmaceutical production processes, including process validation, quality control, and regulatory compliance.
- Program Management: Manage and coordinate process validation activities, including planning, execution, and reporting, to ensure timely and effective delivery of results.
- Education: Bachelor's degree in a scientific discipline, such as biology, chemistry, or engineering.
- Experience: Minimum 5 years of demonstrated experience in the pharmaceutical industry, with a strong background in process validation, quality control, and regulatory compliance.
- Skills: Excellent problem-solving skills, creative thinking, and ability to work effectively in cross-functional teams.
- Knowledge: Current and emerging regulatory strategies, including GMP for the 21st century, ICH Q7, Q8, Q9, Q10, and Quality by Design.
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Biologics Process Validation Director
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Dubai, Dubai, United Arab Emirates GSK Full time**About the Role**We are seeking a highly skilled Biologics Process Validation Leader to join our team at GSK. As a key member of our organization, 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, Quality...
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Biologics Process Validation Director
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Dubai, Dubai, United Arab Emirates GSK Full time**About the Role**We are seeking a highly skilled Biologics Process Validation Leader to join our team at GSK. As a key member of our organization, you will be responsible for leading the technical aspects of the product lifecycle, including technical risk assessments, product control strategies, bench, pilot & commercial scale validation studies, QbD, PPQ,...
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Dubai, Dubai, United Arab Emirates GSK Full timeBiologics Process Validation LeaderWe 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...
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