
Pharmaceutical Validation Specialist
3 days ago
At our organization, we are seeking a highly skilled and experienced Senior Commissioning, Qualification, and Validation (CQV) Trainer to lead our commissioning, qualification, and validation activities. As a Senior CQV Trainer, you will be responsible for ensuring that all equipment, utilities, and computerized systems meet regulatory and industry standards.
Key Responsibilities:
- Lead and execute commissioning, qualification, and validation activities in compliance with regulatory and industry standards.
- Develop and review documentation including user requirements specifications, design qualification, factory acceptance testing, site acceptance testing, installation qualification, operational qualification, performance qualification, and risk assessments.
- Manage and implement validation master plans and system impact assessments.
- Collaborate with cross-functional teams to ensure seamless integration into capital and remediation projects.
- Conduct remote support, data review, and validation strategy planning.
- Support data integrity assessments and 21 CFR Part 11 compliance for computerized systems.
- Ensure documentation complies with GAMP 5, FDA, EMA, and ISO 13485 requirements.
- Oversee execution of validation test protocols, ensuring deviations are captured and resolved.
- Drive continuous improvement and risk-based validation strategies in line with current industry best practices.
Required Skills and Qualifications:
- Bachelor's or Master's degree in Engineering, Life Sciences, or a related field.
- 10+ years of hands-on experience in commissioning, qualification, and validation activities in the pharmaceutical and medical device industries.
- Deep understanding of regulatory requirements (FDA, EU Annex 15, ICH Q8-10, ISO 13485).
- Expertise in GAMP 5, 21 CFR Part 11, and risk-based validation.
- Experience working in remote project environments.
- Proficient in using validation lifecycle software and document management systems.
- Excellent communication and technical writing skills.
Benefits:
- Opportunity to work with a talented team of professionals in the pharmaceutical and medical device industries.
- Chance to develop and implement innovative validation strategies.
- Professional growth and development opportunities.
- A dynamic and fast-paced work environment.
What We Offer:
We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and experienced professional looking for a new challenge, please submit your application today
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