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Quality Assurance Validator
3 weeks ago
We are seeking a highly skilled QA Validation Specialist to join our team. The ideal candidate will have a strong background in software, equipment, and facilities validation.
Job Summary:The QA Validation Specialist will be responsible for reviewing IQ/OQ/PQ protocols and reports for software, equipment, and facilities, ensuring compliance with regulatory requirements.
Key Responsibilities:- Review and approve IQ/OQ/PQ protocols and reports for software, equipment, and facilities.
- Develop validation protocols and reports to ensure compliance with regulatory requirements.
- Manage the site Validation Master Plan and its timely execution.
- Act as a site contact for vendors, including off-site meetings where applicable.
- Provide QA support for equipment qualification, reviewing and approving protocols and reports.
- Contribute to the development of User Requirement Specifications.
- Review and approve vendor-supplied documentation.
The successful candidate will have:
- A Bachelor's Degree in a scientific or engineering discipline.
- Minimum 2+ years' experience in the pharmaceutical industry with excellent working knowledge of cGMP.
- Extensive experience in QA Validation activities.
- Good communication skills both verbally and written, with strong interpersonal and organizational skills.
This is an exciting opportunity for a motivated and detail-oriented individual to join our team and contribute to the success of our organization.
