QA validation Engineer
Capgemini
This job is no longer accepting applications
See open jobs at Capgemini.See open jobs similar to "QA validation Engineer" Imagine.Your role
-
You will give quality assurance oversight on (IQ/OQ /PQ /PV…) protocols and reports,
-
You will help define and support the Validation Approach,
-
You will establish procedures for Validation in accordance with international standards (FDA, EMA, ICH, ASTM E2500, GAMP, CFR),
-
You will perform risk assessments,
-
You will write and approve validation documents (GMP requirements, SOPs, Critical Impact Assessments, …),
-
You will make sure that production practice are aligned with validation conclusion,
-
You will communicate to management about issues in the validation process,
-
You will attend project meetings,
-
You will provide QA oversight and approve deviation,
-
You will pro-actively identify potential quality and compliance risks by managing these risks through the risk register and quality plan process,
-
You will define validation strategies through the change control process,
-
You will write and implement validation documentation (Validation Plan, Validation Summary Report, Risk Assessment, Gap Analysis , Periodic review, ….),
-
You will ensure the correct application of the validation quality systems in the field and define an improvement plan as required,
-
You will support the production, QA and technical service teams in the implementation of validation activities,
-
You will work in close collaboration with production, engineering, maintenance, QC, QA…
Your profile
-
Master’s degree in (Bio-)engineering, Chemistry, Pharmacy or related scientific domains,
-
French or Dutch fluent and fluent in English,
-
A minimum relevant experience of 1 year in the (bio)pharmaceuticals, medical devices or biotechnology sector,
-
Knowledge of GMP / CFR / Eudralex and the different regulations / standards related to validation activities are a big plus,
-
Good interpersonal relationship skills,
-
Problem solving and achievement oriented,
-
Be a good team player in order to succeed in each validation project,
-
Be able to use a risk-based approach for problem solving and prioritization of tasks.
**#LI-CO2 **
This job is no longer accepting applications
See open jobs at Capgemini.See open jobs similar to "QA validation Engineer" Imagine.