Senior Quality Assurance Specialist
We are seeking a skilled Senior Quality Assurance Specialist to play a key role in ensuring compliance with regulatory agencies and maintaining the highest standards of quality.
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* Create and execute validation documentation, including plans, protocols, reports, and amendments, to ensure compliance with regulatory agencies and maintaining the highest standards of quality.
* Generate applicable quality documentation in conjunction with validation activities, such as process characterization and method validation.
* Liaise with cross-functional teams to drive validation inputs and initiatives into operational activities.
* Develop validation projects and master validation plans to maintain a robust quality management system.
* Support implementation of company policies and GMP practices, ensuring ongoing compliance and effective recording of events and processes.
* Perform risk assessments and participate in quality audits to identify areas for improvement.
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Requirements:
* Degree in Engineering or Science discipline.
* 1-3 years' experience in a Validation or Quality engineering role, preferably with knowledge of process validation and capability.
* Strong understanding of EudraLex, ISO13485, ISO14644, GAMP5, and FDA Pharma and medical devices regulations.
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Key Skills and Attributes:
* Excellent technical report writing, time management, computer, and presentation skills.
* Ability to work in a cross-functional team environment with excellent initiative, decision-making, and drive for achieving results.