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Job Details

CSV Engineer

Company: Optimus Search Limited
Location: London
Reference: BBBH9618
Closing Date: 21 Feb 18
Type: Contract
Salary (£): Negotiable
Benefits:

Job Summary:

Are you a CSV Engineer interested in working for one of Irelands leading names in High-Tech Pharmaceutical Engineering?Are you looking for something new?!Then stop what you are doing and read on!

Requirements:

Are you a CSV Engineer interested in working for one of Irelands leading names in High-Tech Pharmaceutical Engineering?
Are you looking for something new?!
Then stop what you are doing and read on!

Title: CSV Engineer

Rate: Negotiable

Location: UK (multiple locations)

Positions Available: 4+

Type: Contract (12 Months Rolling)

A Fantastic new role has just opened up at one of our leading Dublin based clients offering the successful candidate the opportunity to join a hard-working team working on exciting projects in the pharmaceutical sector.

The proposed start date is February - We need YOU

Responsibilities include:

* Ensuring business processes are designed to meet the requirements of relevant good practises (GxP)
* Support the RFP process, solution review and selection
* Validation activities supporting the implementation of a centralised Computer Aided Design (CAD)
* Validation activities supporting the rollout of the Enterprise Quality Management System (Master Control, SaaS)
* Validation activities supporting the implementation of a centralised Product Stewardship system
* Validation activities supporting the development and implementation of interfaces to/from other global systems (SAP, Data Warehouse, Ticketing System)
* Conducts Vendor Audits
* Regulatory considerations of Requirements, Systems, Processes and ensures Requirements are appropriately specified and testable
* Coordinates Business Criticality Risk Assessments
* Coordinate Supplier team through Risk Based compliance approach (Traceability Matrix and Risk Assessment)
* Develops Validation Plans and Test Protocols to define the approach to system verification
* Develops appropriate test scripts, review results, develope testing summary reports and release notes
* Must have extensive experience of Computer Systems Validation (to GAMP5) in the Pharmaceutical / Medical Device / Life Sciences industries
* Good understanding of US FDA (esp. 21 CFR Part 11) and UK MHRA Regulations, ISO Standards, GxP (GMP, GCP, GLP etc)

If you are interested please do not hesitate to email or call me!

Shubert@optimussearch.com

+44 20 30969 392

Apply for this job: CSV Engineer

Contact Information:

Address:  Head Office
171-177 Great Portland Street, London
W1W 5PG
England
Tel:  +44 (0) 20 3418 8033
Fax:  +44 (0) 20 7287 4908
Website:  Visit Our Web Site

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