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Validation Specialist

Req #: 17000A0U_en
Location: Dublin, L IE
Job Category: Engineering
Date Posted: 12/4/2017 10:02:10 AM
Baxter International

Principal Duties and Responsibilities:

·         Lead Qualification and Validation projects, to ensure new equipment and processes are operational on time and existing equipment and processes remain in a validated state

·         Preparation of validation documents / protocols (VMP’s, URS, RTM, DQ,  IQ, OQ & PQ)

·         Execution of Validation activities

·         Adhere strictly to regulatory, cGMP, Standard Operating Procedures, Policies & any other rules defined by the Company

·         Ensure site Validation Master Plan (sVMP) is maintained and activities listed within are actioned in a timely manner.

·         Deviation / Non- Conformance management (Including RCA & CA/PA)

·         Change Control Management

·         Identify opportunities and propose justified solutions for productivity improvements, including automation of manual processes and the use of IT-systems; and to manage their implementation

·         Support the CPI and CQI programmes by training and facilitation of teams

·         Maintain and develop a suite of Metrics and KPIs, to provide direction and reporting information for teams and management in the area of Validation.

·         Participating in and contributing to Baxter  team projects and initiatives as required

·         Partaking in regulatory, corporate and internal audits as required & ensuring validation documents are in a state of “audit readiness”.

Qualifications and Experience:

·         Basic Science, Engineering or Pharmacy  qualification

·         Demonstrate knowledge and understanding of the requirements of the position

·         Project Management experience

·         Hands-on experience in pharmaceutical aseptic production

·         Experience in 6-Sigma and Lean Manufacturing

 

 

Personal Characteristics:

·         Demonstrate skills in problem-solving, system design, application of technological and business tools and the use of IT systems

·         Logical, practical-minded with a hands-on approach

·         Creative, analytical, innovative,

·         Self-motivated and able to motivate others

·         Shows good judgment to achieve a balance between cost:benefit, quality and safety

·         Able to communicate effectively, written and oral

·         Able to manage effectively resources and time

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