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Quality Assurance Expert
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About the Role:
We are seeking a skilled Quality Assurance Expert to join our team. As a senior position within the quality assurance function, you will serve as a Subject Matter Expert in your assigned area of responsibility.
Main Responsibilities:
- Provide overall quality direction and oversight for key functional areas, ensuring that programs, policies, and procedures are robust and aligned with regulatory expectations.
- Quality review and approval of Validation documentation and SOPs to support site validation activities:
- Review of DS & QRAES documents
- Review of validation Plans, Protocols, IQ, OQ, PQ, and associated validation documents
- Review of executed validation documents and reports
- Support a safe working environment by complying with all pertinent environmental health/safety practices, rules, and regulations.
- Provide Quality direction and input at Change Control and Deviation Review Boards and assume QA oversight of change control and Deviation/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely.
- Perform all activities in compliance with quality standards and SOPs.
Key Requirements:
- University degree. Science or Engineering related discipline preferred.
- Relevant experience (7yrs +) working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing overall quality direction and oversight for key functional areas.
- Understanding of principles of Validation and New Product Introduction.
- Experience in change control, non-conformance, corrective and preventative actions, and validation practices.
- Ability to operate across functional boundaries, both internal and external.
- Ability to work independently and remotely with minimum direct supervision.
