Quality & Validation Systems Consultant

Ref. no.: 99825

Tags: CSV Quality Validation Engineer Quality systems Validation ERP Computer Systems Validation Validation Engineer GXP Quality Engineer

Location(s): Dublin West

Salary range (€): Negotiable

Additional benefits: Educational assistance,Parking,VHI,Flexi Start,Canteen,Relocation package

Minimum experience required: 8 - 9 Years

Employment type: Permanent Full-time

Minimum qualification: Third Level Degree

Contact person: Ciaran McArdle

Contact e-mail: dublin@brunel.ie

Job description: Quality and Validation Systems Consultant

My Client is undertaking an ERP Implementation Programme for the next two years. As part of the project, my client is currently recruiting for a Quality and Validation Systems Consultant.

The main purpose of the role is to provide expertise, consultancy and project management skills for a SAP ERP implementation within the area of Quality of a pharmaceutical distribution company.

Specifically the responsibilities of the role will include:

- Assist in the design and implementation of the SAP system to meet current and future Good Distribution Practice (GDP) requirements
- Assist in drafting and reviewing relevant Standard Operating Procedures
- Assist in developing and delivering a training programme
- Ensure SAP implementation and validation is carried out in compliance with regulatory and customer requirements
- Ensure that best software validation practices are employed by the implementation team
- Assist and advise on the creation of URS, DQ, OP and PQ protocols etc where required
- Co-ordinate and monitor the validation phase
- Assist in the validation of system interfaces

Requirements for the role include:

- Relevant third level qualification
- 3 years experience in a computer system validation role preferably in a regulated industry
- Demonstrate a thorough working knowledge of relevant regulations
- Proven systems validation success
- Hands on experience in implementing a SAP solution - an advantage
- Basic understanding of systems interfacing
- Capable of working independently or as part of a team
- Strong communication skills (written and oral)
- High level of attention to details


To apply for this position in strict confidence, please contact Ciaran McArdle in Brunel Recruitment on +353 1 432 1510 or email your full CV to: dublin@brunel.ie


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