Specialist Quality Control Support

Vor 7 Tagen

Schweiz WuXi AppTec Vollzeit CHF 80'000 - CHF 120'000 pro Jahr


Overview

The Quality Control (QC) laboratory at the site of STA Pharmaceutical Switzerland SA performs analytical and microbiological testing of incoming materials, packaging components, in-process samples, drug products, drug substances, and stability studies.

This position is responsible for performing all Super User activities for the QC laboratory computerized systems. This includes at least Audit Trail Reviews and Master Data Management, optimization and/or new method setup, in adherence with data integrity principles as well as end user training, on-the-job training.

Working closely with the Qualification and Metrology teams, this position involves the selection, acquisition, and maintenance of analytical equipment in QC. Responsibilities include leading or supporting troubleshooting activities for laboratory instruments, contacting instrument suppliers for troubleshooting and additional training; handling, writing, reviewing, and executing related documentation and user guidelines.

As a QC Team Member, the person filling this position supports all activities to continuously maintain the GMP status of the QC Laboratory.

As a Senior QC Team Member this position acts as a center of competence reflecting experience, transferring knowledge and supporting other QC team members in all aspects of their daily work.



Responsibilities

  • Super User of Laboratory computerized systems.
  • Performs Audit trail review. Assures adherence to data integrity principles.
  • Manages Master data for Laboratory software (e.g. Empower, Dissolution Workstation, Tiamo, etc.).
  • Applies technical expertise to investigate and resolve issues related to laboratory instruments. Train instrument SMEs on troubleshooting techniques for laboratory equipment.
  • Participate in selection, purchase and commissioning of new equipment.
  • Owns deviation and CAPA related to the Master data and instruments in QC.
  • Evaluates impact of compendial changes on applicable QC procedures and opens change controls as required.
  • Writes and reviews all types of GMP documents (e.g. SOP, TWI, test method, validation protocols and reports, investigation reports, etc).
  • Plays a key role in continuous improvement initiatives within GMP processes.
  • Supports internal and external audits.
  • QC representative in transversal project.
  • Maintains the GMP status of the laboratory.
  • In charge of the support of QC team members ("center of competencies").
  • Supports maintenance/calibration of equipment and keeps relationship with suppliers.


Qualifications

Experience / Education

  • Bachelor's or Master's degree in Analytical Chemistry, Pharmaceutical Sciences, or related field
  • Minimum 5 years of work experience in a GMP environment

Knowledge / Skills / Abilities:

  • Excellent knowledge in HPLC, GC, Dissolution, UV/VIS, IR, TOC, XRPD, PSD.
  • Excellent knowledge of Empower, Dissolution Workstation, Tiamo, Omnis, and other software used in the QC laboratory.
  • Knowledge of analytical method transfer and analytical method validation.
  • Experience of doing analytical testing according to Ph. Eur. and USP prescriptions.
  • Experience in laboratory equipment qualification.
  • Very good communication skills and writing skills.
  • Excellent team spirit.
  • Fluent in English and French.
  • Very good knowledge of most common office software.
  • Good knowledge and/or ability to familiarize themselves quickly with new software and computerized systems (specific instrument software, LIMS).
  • Demonstrates capability for know-how transfer and provides training to other QC team members.

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