Graduate Validation Engineer
4 days ago
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REPORTING TO: Lead Quality Engineer – Validation / NPI
DIRECT REPORTS: N/A
OBJECTIVES OF POSITION:
- To formulate and execute validation plans for medical devices.
RESPONSIBILITIES:
- Support validation activities in a Medical Device regulated environment.
- Support Process Validation Execution in Fermoy.
- Support Software Validation Execution in Fermoy.
- Assist with resolution of Problems encountered during validation.
- Become fully conversant and up to date with GMP requirements for site-wide regulatory body compliance.
- Participate in change control processes for manufacturing process and facility modifications.
Quality:
- Assure ongoing compliance with quality and industry regulatory requirements.
Health & Safety:
- Ensure compliance with Health & Safety Legislation and Regulations.
MEASUREMENTS:
- Timely and accurate completion of Validations.
- Compliance with regulatory Standards and requirements.
PERSONNEL SPECIFICATIONS:
ESSENTIAL:
- Minimum Level 7 Degree/ Diploma (Preferably in a Science, Electronics, Mechanical or Industrial Engineering).
- Sound understanding and utilization of Problem Solving Techniques.
- Proficient in the use of MS Word, Power-point and Excel.
- Ability to write standard operating procedures, training documents, and regulatory responses.
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