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https://www.jobsbiopharma.be/fr/travail/process-validation-specialist-permanent-contract-1554671Description de l'offre
Great Opportunity as PROCESS VALIDATION SPECIALIST for TAKEDA LESSINES !
You have a few years of experience in Process Validation Method or Quality in a pharmaceutical industry?
You have good knowledges of manufacturing processes and expertise in biochemistry?
You have good teamwork skills and critical thinking ?
We have the right job for you !
Read our Process Validation Specialist Offer !
Summary
The Lessines Process Validation Specialist, part of the Lessines MS (Manufacturing Sciences) organization, is responsible for providing the expertise and support for the manufacturing process qualification/validation projects at Takeda Lessines’ production facility (Purification, Filling and Packaging).
He/She will be accountable for the preparation, implementation and documentation of the validation activities required to assure the proper development of a project in accordance to local and global PV strategies while ensuring and maintaining the appropriate validation state of Lessines’ Production Processes.
He/she manages deviations and changes in order to guarantee that these are well documented and that corrective actions are taken and followed-up upon. He/she will support the regulatory submissions and audits related to the process qualification/validation projects.
Responsabilities
Acts as a validation representative for small, mid size and big Process Validation projects within the plant:
Defines, prepares and implements all validation activities related to the project.
Develops the Validation Plans: defines and documents validation methodology and approach. Submits to the Validation Lead for review.
Provides validation expertise for the development of the project.
Participates in the risk assessment related to the project.
Participates in URS, FS and DS definition and writing
Prepares and implements FAT, IQ, OQ & PQ protocols.
Assures requirements traceability throughout the whole project validation file (from URS to PQ).
Organizes and coordinates FAT, IQ, OQ & PQ validation activities with the different involved departments (on the ground, as required) in such a way that all of them concur with the timeframes committed with the project leader.
Analyzes, interprets, documents and reports the testing results.
Ensures the follow-up and tracking of the validation activities. Updates the validation documentation system.
Assures feedback of status and issues to the Validation Lead
Closely collaborates with the PV stakeholders (MS, MQ, production, quality, regulatory, business excellence) to ensure continuous improvement (e.g. process robustness) by controlling the critical PV life cycle from process development, validation, authory submission to routine production
Secures that the process validation status is continuously maintained, following the established local and global PV strategies
Ensures compliance with current GMP and other regulatory requirements and supports corresponding regulatory submission writing and (oral) defenses during regulatory audits
Contributes to international standardization for topics related to process validation
Provides support in all quality-related issues, including GMP regulations, compliance with internal SOPs, and all aspects of safe, reliable and consistent operation of the system.
Assures the ability to meet the Department goals with respect to EHS, Quality, Compliance, Supply and Budget fulfilment
Coordinates activities of junior validation engineers and contractors
Votre profil
Master Degree in Engineering, Chemistry, Life Science, or other job related discipline or equivalent by experience
At least 2 years professional experience in Validation/Quality systems or similar role
Knowledge, skills and ability
Knowledge of Process Validation Methodologies
Knowledge of manufacturing processes and in biochemistry, protein purification, filling and engineering principles
Knowledge of risk assessment tools
Knowledge of data analytics and problem solving methodologies
Project management experience
Knowledge of quality systems, regulations, cGMP, GDP
Excellent verbal and written communication skills (English)
High level of customer orientation
Flexible in mind / out of the box thinker
Complément d'information
We offer you a permanent contract in one of the largest and leading companies in the Bio Pharmaceutical Sector : TAKEDA
Here, the benefits to work for the company TAKEDA as PROCESS VALIDATION SPECIALIST
Attractive salary
Lunch voucher
Refund in the travel expenses (go & return)
Insurances
Interest for this offer ? Don’t hesitate to send your resume !
Personne de contact
Nom :Sophie Flament
Email :sophie.flament@startpeople.be
Tél. :02/397.07.65