Job Description
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We are seeking a highly skilled QA Validation Specialist to join our team.
The successful candidate will have prior validation experience in equipment, facilities, and utilities in a GMP environment. They will be responsible for providing technical expertise, feedback, and guidance for QA and compliance topics/issues, including validation strategy/approach, new product introduction, and manufacturing.
The QA Validation Specialist will also review and approve validation documentation and activities related to the qualification of the facility, equipment, and utilities to support start-up and on-going manufacturing.
Additionally, they will manage assigned areas of Quality Management System (QMS) to ensure the manufacture of product in accordance with GMP and regulatory requirements.
This includes deviation investigations, change control, and CAPA management systems; internal/external audits; vendor management; review/approval of manufacturing batch records; and assessment/approval of production materials.
The QA Validation Specialist will generate, review, and approve SOPs/other documentation as applicable to their areas of responsibility.
They will perform timely review and approval of site procedures and documentation to ensure compliance with GMP and regulatory requirements.
The specialist will also ensure schedules for review and approval of GMP/validation documents are maintained to support technology transfers and new product introduction project timelines.
Finally, they will apply quality risk management principles, including the application of risk assessment tools such as FMEA.
About the Role
* Provide technical expertise, feedback, and guidance for QA and compliance topics/issues.
* Review and approve validation documentation and activities.
* Manage assigned areas of Quality Management System (QMS).
* Generate, review, and approve SOPs/other documentation.
* Perform timely review and approval of site procedures and documentation.
* Ensure schedules for review and approval of GMP/validation documents are maintained.
* Apply quality risk management principles.
What We Offer
A competitive salary and benefits package awaits the successful candidate.
We offer opportunities for professional growth and development in a dynamic and fast-paced environment.
In addition, we provide a collaborative and supportive work environment that encourages teamwork and open communication.
How to Apply
To be considered for this exciting opportunity, please submit your resume and cover letter.