Are you full of energy, love complexity and have a first experience in GMP? This might be the job for you!
Job description
We focus on the labeling, packaging and distribution of the drugs for clinical trials and commercial use, which we have developed and produced at our international sites. The packaging and distribution are supported by the Operations, Customer Service and Demand, Information Systems and Quality departments.
Process Development, Operations and Quality (POQ) are the core divisions of the Client that make sure the drugs are delivered to our patients. Made up of seven functions and spread across seven sites, POQ's aspiration is simple: Supply every patient, every time!
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.
Responsibilities
In this role you act as a QA specialist, you are responsible to provide quality guidance and direction to clinical operations, production, warehouse/distribution staff and global clinical supply chain management (GCSCM) assuring that cGMP standards are maintained.
- 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.
Do the above responsibilities fit you like a glove?
Upload your CV and motivation letter via the "apply now" button and you can expect feedback from us soon.
If something is not entirely clear, you can reach out to us by telephone of course.
Profile
- 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.
What will you bring?
We are looking for people with a passion for their profession!
You are bursting with energy and you cannot wait to start working. You are eager to learn, like to show initiative and you are ambitious about your goals.
You bring:
- Effective communication skills at multiple levels and areas
- Stepping up to address difficult issues, saying what needs to be said
- Thorough decision-making skills and ability to apply Quality risk-based approach
- Making sense of complex, high quantity, and sometimes contradictory information to effectively solve problems
- Drive for results
- Compliance following attitude with high degree of attention for detail
- Nimble learner
Benefits
- A balanced salary package based on your capabilities and experience.
Existing right to work in Europe required ( please read job spec in full before applying ).
Vacancy number : 17093
