Validation Engineer - Thermal Mapping

Carlow  ‐ Onsite
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Keywords

Description

Role - Validation Engineer - Thermal Mapping

Type - initially 11 month contract

Location - Ireland

One of our global Pharmaceutical client are looking for a professional to join their Technical Operations Validation team to validate and provide ongoing technical support to the filling processes at their Vaccines Formulation/Fill facility in.

Key Responsibilities
Validation documentation - drafting, reviewing and approving validation documentation.
To partake in the execution of equipment and Controlled Temperature Units qualification programs
Accountable for scheduling, tracking, reporting and achieving project deadlines
Input into the core aspects of Manufacturing and Cleaning SOP's.
Co-ordinate the execution of the re-qualification program.
Performing data analysis and determine conclusions reached.
Reviewing and signing off data analysis performed by other technical personnel.
Attends departmental and team meetings focused on qualification/validation activities.
Serve as a Technical Operation representative for internal technical group discussions.
Understanding and applying industry specific compliance standards/regulations to all Qualification/Validation activities.
Developing an understanding of the importance considering impact on GMP and compliance on decisions made.
Conducting and participating in Risk assessments and root cause analysis.
Signing off and approving protocols, reports, change controls and deviations.
Proactively highlighting any issues around compliance.
Participates in internal and external audits and inspections.

Key Experience:
Validation experience in vaccine or sterile product manufacturing would be an advantage Thermal mapping experience using Kaye systems
Experience in IMB/FDA environment advantageous.
Strong technical writing and communication skills
Ability to close items to completion.
Ability to pay high level of detail and QA data to very high standard
Problem solving skills.
Project Management skills.
Must be goal-oriented and able to prioritise and manage risks

To apply for this long term opportunity, To apply for this long term opportunity, please send in your CV.
Start date
ASAP
Duration
Initially 11 month contract
From
Quanta Consultancy Services
Published at
18.02.2014
Project ID:
666746
Contract type
Freelance
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