Fill Finish Process manufacturing specialist
SIRE
Zuid-Holland, Netherlands
5 dagen geleden

SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation.

We like technology, in a Life Sciences 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!Our client is a professional Pharmaceutical organisation, based in Zuid-Holland Netherlands.

The Company

Our client is a professional Pharmaceutical organisation, based in Netherlands. In our organization, entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are of crucial importance.

We are continuously looking for enthusiastic, talented people who have the ambition to develop themselves.

Role Description

The individual operates at the technical interface between our company and the (external) DP manufacturing sites. The main purpose of the individual is to ensure proper and timely execution of outsourced DP manufacturing activities in compliance with applicable quality standards, as required for supply of clinical trials.

The related responsibilities range from the selection of the Contract Manufacturing Organization (CMO) in the preparation phase until supporting the QP for the batch disposition.

Responsibilities

  • Accountable for proper and timely execution of outsourced manufacturing activities as defined in programs plans.
  • Responsible for establishing and maintaining a trustful and professional relationship with the external partner
  • Responsible to participate in DPD sub team, ensuring alignment with project needs through Technical Integrator
  • Contribute as required to CMO selection process (accountability / responsibility at Head of Production)
  • Responsible as technical subject matter expert for alignment with QA
  • Responsible for the implementation of the manufacturing process
  • Responsible for review of the documentation prepared by the external partner that is required for manufacturing, and bringing it to the required quality level
  • Responsible for assessing the technical readiness of the external partner prior to starting manufacturing (accountability Head of Production)
  • Technical oversight manufacturing, when required acting as person in plant at the DP manufacturing site resolving issues on the spot and guiding
  • corrective measures if required.

  • Responsible for timely informing / escalating issues to Head of DP manufacturing and Technical Integrator as needed
  • Responsible for ensuring timely closure of DP manufacturing related deviations, changes and CAPAs
  • Responsible to generate the required documentation and provide required support to enable timely and successful batch disposition by the QP
  • Requirements

  • MSc / BSc in relevant discipline, like pharmaceutical sciences, pharmacy, (bio)chemistry or other life sciences or engineering.
  • Good communicating skills in English (Dutch is a plus)
  • In-depth understanding of GMP manufacturing of vaccines and / or large molecules, including relevant unit operations, equipment and facility design, as well as
  • applicable quality and regulatory guidelines.

  • At least 5 years of experience in vaccine and / or large molecule GMP drug product manufacturing.
  • Broad experience in applicable quality and regulatory guidelines, aseptic GMP manufacturing, outsourcing and troubleshooting
  • Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Windimi Post.

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