Report this listing

Solliciteren

Plaats

Noord-Brabant
Noord-Brabant
Nederland

Contract

Vooltijds, Onbepaalde duur

Datum gepubliceerd

2025-02-25

Online tot

2025-04-26
EUR 15.00 HOUR

Ingénieur Validation (H/F)

QbD Group
Noord-Brabant Noord-Brabant
Andere
2 weken geleden

QbD Group's team offers knowledge & tailored (software) solutions in development, clinical, regulatory & compliance, production and distribution for companies active in Pharma, ATMP and Medical Devices/IVD. As a Qualification & Validation specialist,you work on multiple projects in the Netherlands within several organizations within the pharmaceutical, ATMP’s or Medical device related industry . You are responsible for effective and efficient validation and qualification of computerized systems, laboratory equipment, cleanrooms, utilities, HVAC systems, GMP production equipment, medical devices and processes. Provide quality and validation oversight to ensure that validation, qualification and other life cycle activities are consistent with company validation policies, procedures and federal regulations; Support process validations ( IQ/OQ/PQ ) and test method validation; Proceed according to the company's quality policy in all business activities; Provide advice to improve the quality policies and validation procedures Represents Quality Assurance department in project teams; Provide coaching, training and guidance on validations, quality and CSV; Ensure change control procedures are followed to maintain the system including its software in a validated state throughout the life cycle; Implement controls to ensure data integrity and traceability of Quality records ; You have a BSc degree in Life Science & Technology, Exact Science, Computer Science or Engineering; Experience in QA, computer system validation (CSV) or in automated processes and working knowledge of validation of products/equipment/processes/risk management/data integrity; Pro-active, result driven, flexible, detail oriented, and able to function independently as well as in a team. A true QbD’er can be recognized by the following qualities: ~ Resilient : Your strong and positive attitude helps you overcome any challenge ~ As we’re a knowledge-based company , you’re guaranteed to embark on a continuous journey of learning and development.

Solliciteren