Duration: 24 Months
- The individual will provide Quality Assurance oversight in support of various day to day standard review work. The individual will be responsible for the quality review and approval of validation and change control documentation such as protocols, test plans, various validation testing documents, deviations, and change controls. The documentation will span the breadth of validation and change control requirements for biopharmaceutical processing equipment, Computer Systems, Utilities and instruments (both processing and Quality Control Labs) and therefore validation and quality assurance experience in a manufacturing and / or Quality Control laboratory GMP environment is required. The individual will also ensure that the execution of documents adheres to the governing SOPs, protocols, project plans, cGMP, etc. Upon completion of their review, the individual will also be responsible for the release of equipment back to GMP manufacturing.
POSITION RESPONSIBILITIES
- Provide QA review of executed validation documents such as change controls, protocols and test plans, validation testing documents, and deviations.
- Ensure compliance to governing SOPs, validation plans, and protocols throughout the project.
- Release equipment and / or instruments for GMP manufacturing and / or Quality Control use as part of change control.
- Have the ability to independently assess impact and re-testing requirements in the event of a deviation.
EDUCATION AND EXPERIENCE
- Bachelor’s degree in engineering or life sciences
- 5 years of validation/QA experience in a GMP environment
- Experience with change control as a Quality Assurance approver
- 1 year of experience with Trackwise change control software (or similar)
TECHNICAL SKILLS REQUIREMENTS
- Proficient in reviewing executed validation documents (change controls, protocols and test plans, validation testing documents, deviations, etc.)
- Knowledge of cGMP regulations as they pertain to the pharmaceutical/biopharmaceutical industry.
- Thorough understanding of the equipment and / or instrument validation lifecycle, including change control
- Identify and address any potential quality impact throughout the project.
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