QP Trainee

€3000 - €5500 per month

What will you do

As a Sr. Associate QA clinical manufacturing/clinical supply chain – Trainee QP, you will provide quality oversight in the clinical packaging area and you will be providing QA oversight on the supply chain of clinical trial products (including but not limited to study set up and distribution of clinical trial material), ensuring compliance with GDP and GMP requirements. You will be in direct contact with a wide range of stakeholders, and be responsible for establishing effective working relationships with key stakeholders including Global Clinical Supply Chain (GCSCM), Warehouse/Distribution, Production, Site Quality, Clinical Research Management, and Regulatory Affairs. In addition, you will work closely with the clinical Qualified Person, and be included in our in-house QP training program.

What are your responsibilities?

• Provide quality guidance for Investigational Medicinal Products assuring that GDP and GMP standards are maintained, and to support Clinical QA primary processes
• Responsible for batch review to support QP batch certification of Investigational Medicinal Product in compliance with EU and international regulations
• Compliance review and approval of clinical label artwork
• Responsible for assessment of temperature excursions during transport and at clinical sites
• Assist in resolution of compliance and quality issues related to the manufacturing and transport of clinical products
• Review and approve minor deviations ensuring all procedural requirements are met
• Owning and generating operational SOP’s and Work Instructions
• Review of SOP’s ensuring that Corporate, Site and Regulatory requirements are met
• Responsible for preparation of monthly metrics
• Identify issues and work cross functionally to ensure a solution
• Participate in on-the-job training activities to explore the responsibilities of QP.

What do you need to be successful in this role?

• Master in Science degree, preferably in Pharmacy/Medical or Life Sciences.
• Ability to fulfil the requirements of EU directive 2001/83/EC article 49 (Qualified Person) after training.
• Typically 3 years of related Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry with experience in batch record review, investigations and analytical testing
• Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and/or Good Clinical Practice (GCP) knowledge
• Fluent in English.

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.
• Compliance following attitude with high degree of attention for detail
• Effective communication skills and ability to work in cross-functional teams
• Problem solving skills including critical thinking and analytical reasoning
• Drive for results

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