Validation Laboratory Equipment
Il y a 7 mois
Industry
Engineering Services
Category
Quality Assurance & Test
Experience
Mid level
Applications are considered on a rolling basis
**Location**: Multiple locations
**Workspace type**: Hybrid
Follow Capgemini Engineering
Contact Person
Chloé Olivet
**Job Description**:
Your role
You will give quality assurance oversight on (IQOQ / PQ ) 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 review CSV specific SOP’S and Templates
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 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
**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 2 years in the (bio)pharmaceutical sector in a computer systems validation role
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
About the company
Since 2020, Capgemini Engineering (formerly Altran) has been an integral part of Capgemini, a global leader in consulting, digital transformation, technology and engineering services. As a part of the Capgemini family and a global leader in engineering and R&D services, we bring the most powerful innovation for Intelligent Industry to the world of tomorrow: on the road, in the air, on the seas, in rail transport, in energy production, in life science, finance and telecommunications. We have more than 52,000 engineers and scientists in over 30 countries. Our mission to develop technology for an inclusive and sustainable future requires one thing above all: human energy We want to grow. Are you a technology enthusiast, ambitious and would you like to be a part of something big? Are you the ONE for Capgemini Engineering?
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