Quality Control Scientist

Kelly Scientific Genève — Suisse romande
09.10.2019 | Employee | 100%


Kelly Scientific is looking for a Quality Control Scientist for its pharmaceutical partner.  (permanent position)

 MISSIONS 
 

  • You will support as an experienced team member of...

Quality Control Scientist


Kelly Scientific is looking for a Quality Control Scientist for its pharmaceutical partner.  (permanent position)

 MISSIONS 
 

  • You will support as an experienced team member of the QC department the smooth operation of all commercial testing activities.
  • The responsibilities include the selection and implementation of new equipment; handling of deviations, complex investigations and change controls; method set up and validation/verification of raw material testing methods; super user of laboratory computerized systems, master data management of computerized systems (LIMS, ERP, Empower etc.).
  • You will serve as a Subject Matter Expert during internal and external audits and represents QC in interdepartmental or global projects (e.g. for new product implementation).
  • The position requires experience in working with small molecules in oral dosage forms 
RESPONSABILITIES
 
  • Subject Matter Expert (SME) for QC methods, laboratory instruments & software. 
  • Ensure cleaning validation QC-methods are validated/verified and maintained in compliance with local policies, guidelines, and procedures during their lifecycle.
  • Participates in method transfer, method verification and method validation activities.
  • Author and review of all types of GMP documents (e.g. test method, SOP, WPR, validation protocols and reports, investigation reports etc.).
  • Handle deviations and OOS results in collaboration with QA and laboratory management. Execute laboratory investigations in collaboration with QC personnel. 
  • Handle CAPAs and change controls in the applicable software tool. 
  • Manage master data for laboratory software (e.g. StarLIMS, Oracle, etc.). 
  • Super User of Laboratory systems. Manage audit trail review and assure adherence to data integrity principles.
  • Participates to internal and external audits.
  • Takes responsibility in selection, purchase and commissioning of new equipment.
  • Supports maintenance/calibration of equipment and keeps relationship with suppliers. 
  • Support equipment and method troubleshooting. 
  • QC representative in interdepartmental/global projects.
  • Participate to risk assessments & risk management teams.
  • Establish and maintain effective relationships with internal and external team, customers and suppliers
PROFILE
 
  • Bachelor, Master or equivalent in Life Sciences or Chemistry
  • Minimum 5 years' experience in Quality Control / Analytical Research Development in a GMP environment
  • Very good knowledge in HPLC and GC techniques and CDS
  • Very good knowledge of dissolution, UV/VIS and IR techniques
  • Strong knowledge of analytical method transfers and analytical method validation/verification.
  • Experience of doing analytical testing according to Ph. Eur. and USP prescriptions.
  • Good knowledge in software management and Master Data Management.
  • Very good knowledge of most common office software and capability of handling more complex lab software (e.g. LIMS).
  • Knowledge in equipment qualification (GAMP 5, 21 CFR part 11, etc...)
  • Good knowledge of data integrity principles
  • Very good level of English
  • Capability for know-how transfer to and training of other QC team members.
APPLICATION

Thans to apply online

Your contact at Kelly: 
Mrs Karine Legerot
Consultant Professional Staffing Life Science
Kelly Scientific Geneva

ABOUT KELLY

Kelly Services® is a global leader in providing staff solutions and active in more than 40 countries.
Together with its subsidiaries, Kelly offers a wide variety of outsourcing and consulting services as well as staff services,
from permanent and management positions to temporary positions.
For over 70 years, we have worked with passion and commitment to connect talents with companies.
With more than 200 employees in over 40 branches and specialist departments,
Kelly Services (Switzerland) AG has been active in Switzerland since 1979.

www.kellyservices.ch
 

09.10.2019
Employee, 100%

Contact

Kelly Scientific Genève
Karine Legerot
Rue du Rhône 114
1204 Genève
Fax: +41227371213
Kelly Scientific Resources
rue du Rhône 114
Geneve

Industry

Human resources / Personnel services
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