Description
JOB DESCRIPTION:- Develop pFMEA documentation to support processes as part of Validation process
- Participate in the design of systems and equipment to ensure that they comply with GMP requirements
- Compile Technical content from Team Members' for Validation protocols & reports
- Develop validation documentation as required (e.g. URS, Val Plan, FAT, SAT, IQ, OQ, PQ, procedures)
- Ensure the timely approval of protocols & reports
- Liaise with and direct supplier submission of supplier validation documentation (e.g. FDS's, FRS, SRS's.)
- Manage the Validation activities with Engineers to ensure alignment with documentation
- Execute qualification protocols as required
- Liaise with Regulatory for potential market implications and generation documentation as needed for submission
- Initiate and implement change control activities
- Track and resolve exceptions during qualification activities
- Prioritize qualification activities in line with the project schedule
- Assist in the development of training material for qualification activities
- Liaise with Operation and Process Engineering to align with process metrics required
- Report out on VS process Metrics
- Domestic and international travel may be required
PRINCIPLE ACCOUNTABILITIES:
- Validation compliance for new project
- Managing approval of validation documents with Supplier and Team
- Liaising with Regulatory for potential market implications
KEY COMPETENCIES REQUIRED:
- Excellent Communication Skills Highly computer literate
- High attention to detail
- Pro-active approach to work
- High work standards
QUALIFICATIONS & EXPERIENCE EXPERIENCE ESSENTIAL:
- Degree Quality/Manufacturing/Engineering
- Minimum of 3-5yrs experience in Quality Assurance/Engineering (a minimum of 3yrs of which has been spent carrying out validations)
- Experience with working in Automation projects
- Experience in generation and managing teams participation in pFMEA
- Familiarity in areas of various inspection techniques
- Excellent interpersonal & communication skills
DESIRABLE:
- In depth knowledge of 21 CFR 820, CFR 11 and European regulations associated with the medical device industry
- High understanding of GMP, Compliance, Validation practices including the system development life cycle and regulatory expectations
- Working knowledge of Quality systems (FDA/ISO) within a regulated environment