Description
RESPONSIBILITIES:- Own and support facility validation activities in a regulated Medical Device environment.
- Participate in URS and PFMEA development
- Formulate Master Validation Plans IQ, OQ and PQ Protocols and Test Reports for new and modified facilities.
- Responsible for Facility validation Execution in conjunction with SME
- Interpret customer and contractor specifications, drawings and critical attributes for assessment during validation activities.
- Resolution of oversight and resolution of Problems encountered during facility validation including scripting of 'notes to file' and 'Validation Deviations' as appropriate
- Provide guidance and direction in the preparation and execution of facility validation activities and changes.
- Maintain facility Validation system and Register including conducting Periodic Reviews
- Participate in change control processes for manufacturing facility modifications
ESSENTIAL SKILLS AND QUALIFICATIONS
- Degree Educated in relevant Science or Engineering discipline
- Minimum of 4 years Quality Assurance / Regulatory affairs experience.
- Experience in working within a Medical Device Manufacturing Environment.
- Experience in HVAC, Compressor, Vacuum System or similar installations and their validation in terms of both viable and non viable particles.
- Problem solving Facility Validation challenges and issues.
- Generation and review of system level risk analysis / FMEA / Impact Assessment for facility/utility installations and upgrade.
- Sound understanding and utilization of Problem Solving Techniques
- 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.
- Technically Competent.
- Experience in statistical Analysis / DOE / MSA / Mathematical Modeling.
- Ability to understand and apply a risk based approach to validation of facilities/utilities and a knowledge of leveraging as per Baseline guides for facilities/utilities.