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QA CSV Engineer

  • Job reference: 931594
  • Location: Cork
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Building, Construction & Infrastructure
  • Date posted: 05/08/2020

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.

EXPERIENCE ESSENTIAL:
* Hons. 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.


DESIRABLE:
* 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


Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.