Overview

This position is responsible to perform all type of analytical testing that is required for release of raw and packaging materials, final product and stability samples as well as all IPC testing. Additional responsibilities can be the support of stability studies, handling of deviations and change controls.

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

Qualifications

Experience / Education

• Federal Certificate of Capacity as Laboratory Technician or similar education
• 2 — 3 years of work experience in a GMP environment

Knowledge / Skills / Abilities:

• Good knowledge and interpretation of cGMP and regulations applicable to the Quality Control environment.
• Good knowledge of analytical method transfer and analytical method validation
• Solid knowledge in HPLC and GC techniques and CDS
• Knowledge of dissolution, UV/VIS and IR techniques.
• Experience of doing analytical testing according to Ph. Eur. and USP prescriptions.
• Good writing skills.
• Excellent team spirit.
• Good knowledge in English and French.
• Knowledge of most common office software.

Responsibilities

• This position is responsible to ensure all EHS requirements in the laboratory :
  • Respect EHS procedure and rules
  • Report immediately all incidents and near-misses to the management and/or to the EHS representative people
• Performs analytical testing according to raw material and product release specifications (HPLC, GC, UVNIS, IR, dissolution, pH, conductivity, TOC, titration, weighing, wet chemistry experiments etc.).
• Performs review of analytical data.
• Performs basic laboratory work (buffer preparation, waste disposal management, washing of lab dishes, cleaning of the labs etc.)
• Supports management supply of consumables.
• Supports maintenance/calibration of equipment and keeps relationship with suppliers.
• Supports stability studies (set up, sampling, testing, coordination)
• Writes specific standard operations procedures (e.g. operation and maintenance of equipment)
• Participates in method transfer and method validation activities
• Supports selection, purchase and commissioning of new equipment.
• Handling of deviations and change controls
• SME for the new LIMS introduction for bulk, equipment and stabilities parts:
  • Maintain and update master data objects.
  • Provide expertise in the development of system enhancements with user requirements and business drivers.
  • Hypercare activities.
  • Provide end user training and on-the-job training (OJT) for laboratory and production employees where required.
  • Design, review and/or execution of user acceptance testing (UAT) protocols.
• Acts as a SME for other defined areas
• Can be assigned special tasks and project work