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QA Validation Engineer

  • Job reference: 931613
  • Location: Cork
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Engineering, Manufacturing & Facilities, Life Sciences
  • Date posted: 06/08/2020

1. Prepare periodic validation review documentation for approval by the business units.
2. Maintain site validation registry.
3. Ensure validation activities completed comply with US and EU relations, GBSC procedures and EHS requirements.
4. Review and approve documents prepared by project teams, other departments and contractor organizations (e.g. protocols, reports, change controls)
5. Assist in development of validation strategy and validation plan for equipment and process validations.
6. Assist in the development of sampling plans, test plans and data analysis related to process validation.
7. Assist in resolution of deviations/ exceptions during qualification activities
8. Assist with change control activities in accordance with site procedures
9. Attend identified training, required to fulfil the role of QA Validation Engineer
10. 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.
11. Participate in cross-functional teams as required.

EXPERIENCE ESSENTIAL:

* Hons. Degree Quality/ Manufacturing / Engineering / Science
* Minimum of 2 years' experience in Quality Assurance/Engineering
* Minimum of 1 years' experience in Process, Equipment and Test Method Validation
* Working knowledge of Quality systems (FDA/ISO) within a regulated environment
* Ability to analyze Capability data using MINITAB
* Ability to interpret Engineering drawings/specifications
* Familiarity in areas of various inspection techniques
* Excellent interpersonal & communication skills

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.

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