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Job Details

QA Validation Associate (MES)

Company: Optimus Search Limited
Location: Cork
Reference: BBBH10049
Closing Date: 29 Mar 18
Type: Contract
Salary (£): Negotiable

Job Summary:

Are you a QA Validation Associate (MES) interested in working for one of Irelands leading names in therapeutics?Are you looking for something new?!Then stop what you are doing and read on!


Are you a QA Validation Associate (MES) interested in working for one of Irelands leading names in therapeutics?
Are you looking for something new?!
Then stop what you are doing and read on!

Title: QA Validation Associate (MES)

Rate: Competative

Location: Ireland - Cork

Type: Contract (12 Months)

A Fantastic new role has just opened up at one of our leading Cork 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 January 2018 - We need YOU

Responsibilities include:

* This position is responsible for the review and approval of the introduction of MES in a GMP regulated environment, this will involve the design and implementation of a MES system, and creating the validation strategy for implementation and working with IT-CSV on the validation documentation, and the execution of validation testing.

* Gather user requirements in relation to controlling and recording manufacturing activities
* Map existing manufacturing processes (warehouse, equipment management & EBR) to MES
* Design deployment and oversight of MES systems to replace paper based or manual systems in a pharmaceutical environment
* Oversight of the implementation of MES solutions and integration with ERP and control equipment
* Oversight of documentation of MES configuration and validation of EBRs
* Review and approval of validation lifecycle documentation.
* This position will require interaction with multiple levels (from technicians up through Sr. Management) in Quality Assurance, IT CSV, IT, Corporate Compliance, Manufacturing, Facilities, Regulatory Affairs, Accounting, and Human Resources.
* Lead and represent Validation in multi-departmental meetings & project teams.
* Identifies and implements improvements to the QA Validation systems.
* Participation in the change control program for modifications to qualified systems.
* Coordinate validation activities involving cross-functional, multi-departmental teams
* Strong knowledge of supply chain management and/or manufacturing processes, having the ability to implement strategies to improve the efficiency of the process
* Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured by BioMarin, validation techniques/approaches and systems utilized at BioMarin
* Experience of developing Electronic Batch Records (EBR) may be an advantage


* Minimum of 5 + years’ experience in a highly automated manufacturing or pharmaceutical environment
* Must have experience in implementing an MES solution (Werum, Rockwell, Emerson etc) as well as having experience in integrating these systems with ERP and/or control equipment
* Organizational and management skills to coordinate multi-discipline project groups
* Ability to speak, present data, and defend approaches in front of audiences and inspectors
* Knowledge of FDA and GMP guidelines a must
* Bachelor of Sciences degree, or higher, in a technical discipline (physical, engineering, IT, chemical or biological sciences) is required.

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

+44 20 30969 392

Apply for this job: QA Validation Associate (MES)

Contact Information:

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

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