The Company
Our client is a global leader in advanced cell therapy, specializing in developing and delivering cutting-edge treatments for patients with serious illnesses. The organization operates state-of-the-art manufacturing facilities and follows the highest GMP standards to ensure quality and safety.
Role Description
As a Senior Quality Engineer, you will be responsible for providing quality oversight for MES and Computer System Validation (CSV) projects, ensuring compliance with GMP and regulatory requirements. You will review and approve validation deliverables, support Werum PAS-X validation activities, and drive continuous improvement initiatives within a pharmaceutical manufacturing environment.
Responsibilities
- Provide Quality oversight for MES and Computer System Validation (CSV) projects, ensuring compliance with GMP and regulatory standards.
- Review, approve, and maintain CSV validation deliverables, including initial validation, change control, and periodic revalidation activities.
- Support Werum PAS-X MES qualification and validation activities within a pharmaceutical manufacturing environment.
- Collaborate with cross-functional teams to implement process improvements, quality initiatives, and risk management strategies.
- Support CQV activities, quality risk assessments, audits, and continuous compliance improvement programs.
Requirements
- Bachelor’s or Master’s degree in Engineering, Life Sciences, Quality, or a related technical field.
- Proven experience in Computer System Validation (CSV), MES validation, and GMP/GxP regulated environments.
- Must have hands-on experience with Werum PAS-X MES.
- Strong knowledge of validation lifecycle (IQ/OQ/PQ), change control, deviations, and quality systems.
- Experience with risk management tools such as FMEA/HACCP and continuous improvement methodologies (Six Sigma/DMAIC) is preferred.
Other Information
Apply to our vacancy for more information. We look forward to hearing from you!
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Ayub Sohail
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