- Reference: CJ44471
- Job Type: Contract
- Location: Cork, Cork City, Munster
- Category: Engineering, Technical & Manufacturing
The QA Process Validation Engineer, plays a key role in the planning and execution of validation activities related to new product introductions, product transfers, new technologies and process changes. Provides support for the validation activities associated with equipment & processes ensuring that all compliance issues and requirements of Company validation policies and procedures are addressed.
- Ensure validation activities completed are in compliance with US and EU relations, GBSC procedures and EHS requirements
- Assist in development of validation strategy and validation plan for equipment and process validations.
- Assist in the development of sampling plans, test plans and data analysis related to process validation.
- Review and approve documents prepared by project teams, other departments and contractor organizations (e.g. protocols, reports, change controls)
- Review and approve documents prepared by project teams, other departments and contractor organisations (e.g. commissioning test plans, impact assessments, change controls)
- Assist in resolution of deviations/ exceptions during qualification activities
- Assist with change control activities in accordance with site procedures
- Attend identified training, required to fulfil the role of QA Process Validation Engineer
- Support the QA Validation team leader in driving improvements within the Validation and Change Control processes to streamline the validation activities associated with Process Changes, Product Transfers and/or New Product Introductions
- Support the QA Validation team in developing and standardizing guidance for introduction and qualification of processes and equipment to the site
- Assist in the development of training material for qualification activities.
- Mentoring of Quality/Engineering colleagues with respect to validation activities.
- Participate in cross-functional teams as required.
- Domestic and international travel may be required.
- Excellent Communication Skills
- Pro-active approach to work
- Team Player
- Highly computer literate
- High attention to detail
- High work standards
- Planner & organiser
- Active listener
Qualifications & Experience
- Hons. Degree Quality/ Manufacturing / Engineering / Science
- Minimum of 3-5yrs experience in Quality Assurance/Engineering (a minimum of 2 years of which has been spent carrying out validations)
- Working knowledge of Quality systems (FDA/ISO) within a regulated environment
- Process validation experience
- Ability to analyse Capability data using MINITAB
- Ability to interpret Engineering drawings/specifications
- Familiarity in areas of various inspection techniques
- Excellent interpersonal & communication skills
- Equipment qualification and test method validation experience
- Six Sigma Certification (Green Belt / Black Belt)
- In depth knowledge of 21 CFR 820, 21 CFR 11, ISO 13485 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
For a confidential discussion and more information on the role, please contact Eloisa Ruiz on 021 4809118 or email email@example.com
For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie
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