Objectives
To own and support validation activities in a Medical Device regulated environment.
Responsibilities
- Own and support validation activities in a Medical Device regulated environment.
- Responsible for assigned Process / Equipment / Facility / Utility / Software and Computer System Validation as assigned.
- Generate Validation Plans, Protocols and Reports in support of assigned validation activity.
- Resolution of Problems encountered during validation.
- Ensure Consistency in validation/qualification approach across systems and projects.
- Provide guidance and direction in the preparation and execution of validation activities
- Be fully conversant and up to date with GMP requirements for site-wide regulatory body compliance.
- Maintain Validation system including conducting Periodic Reviews.
- Participate in change control processes for manufacturing Process / Equipment / Facility / Utility / Software and Computer System 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 Specification
Qualifications and Experience:
- QQI Level 7 Degree Preferably in a Science, Electronics, Mechanical or Industrial Engineering.
- Experience in working within a Medical Device Manufacturing / Pharmaceutical Environment.
- Minimum of 1 year Quality Assurance / Regulatory affairs experience.
- Experience of supporting or completing Process / Equipment / Facility / Utility / Software / Computer System Validation.
- Experience in statistical Analysis / DOE and DMAIC methods.
- Experience in using the GAMP 5 approach is preferable but not essential.
Core Competencies:
- Technically Competent.
- Sound understanding and utilization of Problem Solving Techniques.
- Proficient in the use of MS Word, Power-point and Excel.
- Ability to respond to common inquiries or complaints from internal customers and regulatory agencies.
- Ability to write standard operating procedures, training documents, and regulatory responses.
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