One of our clients is looking for a LIMS Laboratory Specialist II. Do you have a Bachelor or Master degree in analytical chemistry or equivalent experience? Read this vacancy!

Functie

Utilize and Maintain various laboratory information management systems like Labware LIMS and computerized databased System (CDS) like Waters Empower. Experience with pharmaceutical processes, chemical analysis techniques, and cGXP

Share best practices, challenges and lessons learned within the site across the Quality organization in order to improve the performance of quality globally.

As a SME’ should be familiar with following business processes:

  • Raw Material & Packaging Components;
  • Finished project & In process bulk testing;
  • Stability testing background;
  • Assistance in the development, validation and implementation of the quality control programs to ensure reliability of testing procedures, proper function of laboratory equipment and compliance with regulations; prepare and maintain applicable records;
  • Handling in the preparation, review and finalization of specifications, standard test procedures and standard operating procedures;
  • Execute according to high standards of quality at the lab through managing and continuously improving the effectiveness of laboratory quality processes and system;
  • Maintain own technical expertise, personal skills and interpersonal skills needed to perform their duties in line with Teva and Site expectations;
  • Provide all necessary input for requirements and data mapping;
  • Participate in workshops and Create /Update/Approve Business SOPS & Work Instructions & other documentation as necessary;
  • Create, update and review Product Specs and Analyses spreadsheets;
  • Participate in the validation process, the Data Qualification process and in the training process;
  • Review Data Load Summary Report; URSs, FSs and SDSs in HPQC gALM system; TSs and execute functional Test runs in the gALM system; Data Qualification TSs and execute Data Qualification Test runs in the gALM system;
  • Understanding and initiation of Deviations including risk and impact assessments and understanding and initiation Change Control required for the introduction new software, equipment or retirement.

 

 

Functie eisen

  • Bachelor or Master degree in analytical chemistry or equivalent experience;
  • Preferentially experience at least 2-3 years;
  • Knowledge of computerized systems ( i.e. LIMS/Empower ) and Laboratory equipment also in the field of environmental monitoring;
  • Strong knowledge of the site business processes with respect to all Laboratory and Quality functions;
  • Excellent organizational skills and a strong analytical oriented mindset;
  • Compliance should be your second ‘nature’ (GMP);
  • Good scientific analytical attitude;
  • Excellent written (English) and verbal communication skills (English and Dutch);
  • Pro-active team player;
  • Results oriented.
  •  

Aanbod

This is a responsible job with good employment conditions.

Sollicitatie Procedure

Contactpersoon voor deze functie is Joost Storms, bereikbaar op telefoonnummer 023 55 78 529 of via e-mail: joost@xdes.nl Kenmerk: 10655.

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Vacature: LIMS Laboratory Specialist

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