Contract: Specialist QA / The NetherlandsClick here to shortlist this job 1-CLICK Apply With Employer or Register Now
|Location:||Breda, North Brabant, The Netherlands|
The client is looking for Specialist QA clinical manufacturing/clinical supply chain based in the Breda Area (Netherlands) on an initial 12-month contract.
As a QA specialist clinical manufacturing/clinical supply chain, you will be mainly responsible for providing QA oversight on the supply chain of clinical trial products, QA guidance and support in the production area and clinical product disposition.
In this role, you will be in direct contact with a wide range of stakeholders, and you will be responsible for establishing effective working relationships with Global Clinical Supply Chain (GCSCM), Corporate Quality, Contract Manufacturing Quality and Site Quality, Clinical Research Management, Regulatory Affairs and Clinical Research Associates/Clinical Research Organizations, Clinical Production operators, line leads, warehouse, maintenance, and engineering.
Main Responsibilities of the role
* Identify issues and work cross functionally to ensure a solution.
* Collaborate cross functionally as needed to ensure the Quality Management System processes are executed in accordance with established procedures
* Perform review, approval and tracking of cGMP processes, procedures, documents and records, including but not limited to SOP`s, Deviations, CAPAs, Change Control records and validation records. May also support execution of these tasks
* Act as a QA contact for deviations and complaints by participating in investigations, root cause analysis and CAPA`s
* Perform impact assessment as part of change controls impacting production or clinical QA processes
* Assist in risk assessments and validation activities as needed including review and approval of applicable documents.
* Support Continual Improvement initiatives, programs and projects as a SME
* Represent the quality unit during audits and inspections as needed
* Provide QA oversight on LSP`s.
* Assist in the development of GMP and Quality Systems training activities and provides training
* Alert senior management of quality, compliance, supply and safety risks
* Develop and establish and maintain effective working relationships with GCSCM, Corporate Quality, Contract Manufacturing Quality and Site Quality, Clinical Research Management, Regulatory Affairs and Clinical Research Associates/Clinical Research Organizations
* Develop and maintain effective partnering relationships with customers and stakeholders.
- Master's in science in Pharmacy or equivalent
* Previous experience in a GMP environment
* Thorough knowledge of the processes involved in clinical and commercial manufacturing (GMP), warehousing and supply chain.
* Understanding of pharmaceutical development and clinical trial processes is preferred.
* Knowledgeable and skilled to fulfill the requirements of EU directive 2001/83/EC article 49.