Senior Quality Assurance Professional
3 days ago
We are seeking a Quality Assurance Specialist to lead the development of engineering and project documentation, ensuring compliance with industry standards.
This role requires strong expertise in quality assurance, specifically cGMP. The successful candidate will be responsible for developing and maintaining engineering documents, including certificates, calibration, test results, inspection requests, and non-compliance reports.
Develop and maintain Engineering/Project documentation.
Prepare Qualification documents (URS, DQ, IQ, OQ & PQ) for production and utility equipment.
Manage Engineering documents, including certificates, calibration, test results, inspection requests, non-compliance reports, and site instructions/observations.
Perform factory acceptance testing at vendor sites.
Qualify new equipment and conduct periodic re-qualifications for facility, utilities, and PW plant HVAC systems.
Develop and review SOPs for the Engineering department.
Provide training and approval for Qualification SOPs.
Develop Facility qualification documents and Project-specific qualification plans for major changes.
Prepare and install operational qualification protocols and reports, as well as performance qualification protocol and reports.
- BE/BTech in Chemical or Mechanical Engineering.
- 2-4 years of experience in Engineering/Project documentation.
- Strong written and verbal communication skills.
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