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QP / Pharmacist Clinical

SIRE Life Sciences®

Netherlands, zagranica

SIRE Life Sciences®

QP / Pharmacist Clinical

Location: Netherlands

SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!

THE COMPANY

Our client is a professional Pharmaceutical organization, based in Noord-Brabant Netherlands.

The client wants to serve patients. They develop and produce medicines and therapies that restore health or save lives.

ROLE DESCRIPTION

The Clinical QA team is responsible for all QA-matters in relation to the clinical products used in our phase 1/ 2 /3 clinical studies running in 57 countries. The Clinical QA team has QA oversight for all clinical products received, released and distributed from the clients facility to ensure adequate, effective and efficient use of the Quality system, programs and procedures.
Moreover, some members of the Clinical Quality team act as a Qualified Person. They release Investigational Medicinal products used in EU clinical studies, manage Quality Agreements and sign QP declarations and more.

RESPONSIBILITIES

You will interact with numerous stakeholders in various functions such as International Quality, Regional Supply Chain, Site Supply Chain and local markets. You work in teams and communicate effectively with all kind of stakeholders across the organization.
More specifically you will:
- Handle Product Disposition
- Act as QA contact for all activities related to new product introductions and product life cycle management including, but not limited to, change control review, deviations and approval.
- Provide guidance and direction to Quality, Production, Warehouse/ Distribution and Supply Chain staff in regards to compliance with quality policies, standards and procedures.
- Act as QA contact for Non-conformances and Corrective And Preventive Actions (CAPA).
- Lead and participate in internal and external audits as needed.
- Write, review and approve procedures and/or job aids in compliance with corporate, site and regulatory requirements.
- Participate in global Quality initiatives ensuring that input from the client is provided and lead implementation activities on our site.
- Participate/lead in various improvement efforts and projects including (new) product launch teams.

REQUIREMENTS

- Master degree in Science in Pharmacy, Bio-engineering, Bio-medical Sciences, Life Sciences or similar educational background.
- Min. 2-3 years of work experience in the pharmaceutical industry and in GMP environment. Experience with “Change controls” and “Deviations”.
- Eligible to become approved as Qualified Person, meaning you are knowledgeable of and skilled to fulfil the requirements of EU directive 2001/83/EC article 49 (Qualified Person) and/or GDP guidelines 2013/C 343/01 chapter 2.2 (Responsible Person). Preferably, but not required, you already have had your first experience as Qualified Person (QP) or Responsible Person (RP).
- Fluent in English, good oral and written communication skills.
- Preferably, but not required, you have experience with working in cross-functional teams and in an international working environment.

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Amber Moet.

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SIRE Life Sciences®

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