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Quality Assurance Professional
2 weeks ago
We are seeking a skilled professional to drive quality and reliability in our products throughout the development lifecycle. As a lead, you will be responsible for developing and implementing validation strategies and processes to ensure the quality of products.
You will collaborate with cross-functional teams to define validation requirements and priorities, establish validation plans, protocols, and procedures, and oversee the execution of validation activities.
The ideal candidate will have:
- At least 6-12 years of experience in validation, preferably in the pharmaceutical or medical device industry.
- Strong knowledge of regulatory standards (e.g., FDA, ISO, MHRA) and industry best practices.
- Excellent communication and leadership skills, with the ability to manage relationships with external vendors and contractors as needed.
- Able to perform risk assessments and develop risk mitigation strategies to address potential product risks related to validation.
- Experience with IQ/OQ/PQ, software validation, and process validation.
The selected candidate will lead and manage a team of validation analysts, providing guidance, coaching, and mentorship to ensure their professional growth and development. They will also be responsible for ensuring end-to-end documentation and traceability of validation activities.
This role requires regular updates and reports on validation activities to stakeholders.
Please apply only if you have relevant experience or share this opportunity with a friend or colleague seeking a change.
