Senior Quality Control Analyst

Vor 6 Tagen

Couvet, Schweiz STA Pharmaceutical Switzerland SA Vollzeit
Overview

As a Sr QC Analyst, with a CDMO organization, you will perform a wide variety of chemical or biological analyses on products, in-process materials, or samples in support of the company's quality assurance and quality control program.

Qualifications

Experience / Education

  • You should have a BS/BA in Life Sciences or related field.
  • Minimum of 7 years' experience in Pharma/Biotech/CDMO, Quality control laboratory. HPLC/UPLC and Empower required.
  • Experience in SE-UPLC, peptide and glycan assay desirable. Speak fluent English (C1); French is a big plus. 

Required Skills:

  • Chemistry
  • AS&T
  • Microbiology
  • Stability

You are living "closer" to the Neuchatel region, or within a maximum of 1,5 hours commuting by car or train or can relocate to this amazing region. The site offers a wonderful natural environment. A private car is highly recommended.

Responsibilities

Essential Job Functions:

  • Performs analytical testing according to raw material and product release specifications (HPLC, GC, UV/VIS, IR, dissolution, pH, conductivity, TOC, titration, weighing, wet chemistry experiments etc.).
  • Performs review of analytical data.
  • Writes and reviews all types of GMP documents (e.g. test method, SOP, WPR, validation protocols and reports, investigation reports etc.
  • Handles deviations and OOS in the applicable software tool.
  • Handles change control in the applicable software tool.
  • Supports internal and external audits.
  • Takes responsibility in method transfer and method validation activities.
  • Takes responsibility in selection, purchase and commissioning of new equipment.
  • QC representative in transversal project.
  • In charge of the support of QC team members ("center of competencies").

Objectives

Within the first 2 weeks, you will...

  • Gain a comprehensive understanding of WuXiApptec Quality Control, Quality assurance and EHS processes and standards, specifically focusing on the nuances of the site testing functions as well as a comprehensive use of all site IT systems linked to the quality control department.

From the third week...

  • You'll gain practice in the laboratory. This includes familiarization with testing procedures for samples, raw materials, drug substances, and drug products. You'll be accompanying colleagues through each of the laboratory department: AS&T, Chemical, Microbiology, Stability and Packaging. You'll also start to Implement Lean methodologies within the Quality Control department.

From the fourth week...

  • You'll be ready to be involved in the current planning, analysing under current processes, identifying areas for efficiency improvements, and suggesting changes that could enhance the overall productivity and effectiveness of testing functions.

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