Engineering & Electronics
QA CSV Engineer
PE Global is currently recruiting for a QA CSV Engineer on behalf of our client based in Cork. This is an initial 12 month contract role.
The QA Computer System Validation Engineer plays a key role in the planning and execution of validation activities related to new product introductions, product transfers, new technologies and system changes. Provides support for the validation activities associated with equipment & systems ensuring that all compliance issues and requirements of Company validation policies and procedures are addressed. Provides support for the periodic validation reviews and administration of the site validation master plan.
MAIN DUTIES & RESPONSIBILITIES:
- Ensure computer system validation activities completed are compliant with internal procedures and external regulations and standards.
- Review and approve documents prepared by project teams, other departments and contractor organizations (e.g. protocols, reports, change controls)
- Assist in development of validation strategy and validation plan for computer system validations.
- 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 Computer System 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 system changes and new technology development.
- Participate in cross-functional teams as required.
- Computer System Validation input for equipment and computer systems including new technologies.
- Adherence to site validation procedures and regulatory requirements.
- Adherence to site procedures.
QUALIFICATIONS & EXPERIENCE:
- Degree Quality/ Manufacturing / Engineering / Science or related field
- Minimum 2 years of related industry experience.
- Minimum of 3 years’ experience with automated system development or operation.
- Strong knowledge of Quality systems (FDA/ISO) within a regulated environment including 21CFR Part 11.
- Strong knowledge of system development life cycle and GAMP.
- Validation experience with automated manufacturing system.
- 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
Interested candidates should submit an updated CV.
Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to email@example.com