Job Description
This is an exciting opportunity for a skilled and experienced validation professional to join our organization.
We are looking for a detail-oriented and organized individual who can create and execute validation documentation to ensure compliance with regulatory agencies directives within the medical device and pharma sector.
The ideal candidate will have knowledge of process validation and capability, with experience in method validation and process characterization.
They will be responsible for ensuring ongoing compliance with GMP and driving quality initiatives forward.
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Required Skills and Qualifications
* Hold a degree in Engineering or Science discipline.
* 1-3 years' experience in a Validation or Quality engineering role.
* Strong knowledge of validation and quality principles, with emphasis on EudraLex, ISO13485, ISO14644, GAMP5, and FDA regulations.
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Key Responsibilities
1. Create and execute validation documentation to ensure compliance with regulatory agencies (HPRA, FDA) directives within the medical device and pharma sector.
2. Develop and maintain quality documentation in conjunction with validation activities.
3. Liaise with cross-functional teams to provide and drive validation inputs into operational activities.
4. Collaborate with external vendors to develop validation plans and requirements.
5. Lead the development of validation projects and master validation plans.
6. Support the implementation of company policies and GMP.
7. Ensure ongoing compliance with GMP in all practices, recording of events and processes.
8. Perform and generate risk assessment documents for regulated processes within the QMS.
9. Participate in and drive quality GMP audits.
10. Apply LEAN 6 sigma tools for problem-solving.