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QA ecompliance Expert

Entreprise
GlaxoSmithKline Plc Switzerland
Lieu
Vaud (La Côte)
Date de publication
06.12.2016
Référence
243501

Description

At GSK we have a challenging mission: to improve the quality of human life by enabling people to do more, feel better and live longer.  As one of the leading Pharmaceutical Companies our prescription medicines include treatments for a wide range of conditions such as asthma, heart and circulatory disease.  We produce more than 30 prescribed vaccines worldwide to prevent potentially life-threatening or crippling illnesses such as hepatitis A, hepatitis B, whooping cough, measles, mumps, rubella, polio, typhoid, influenza and bacterial meningitis.  To support our mission we are currently looking for a

 

QA eCompliance Expert

Main Purpose of the Role:

Coordinate QA e-Compliances activities for computerized systems within Nyon Plant.


Your Responsibilities:

  • Responsible for the full execution of the annual plan. Manage several CSV projects as once
  • Review and approve all computerized systems key validation deliverables and major changes for systems as QA representative
  • Review and approve change requests of GxP validated computerized systems. Investigate deviations and define appropriate corrective and preventive actions to avoid re occurrence
  • Drive and provide internal CSV training of Systems Owners and Project Managers
  • Maintain and make approved local CSV procedures
  • Lead and support inspection related to e-Compliance
  • Plan and conduct assigned vendor audits of computerized system and computerized or service suppliers.

Your profile:

  • Minimum Bachelor of Sciences in Engineering, Pharmacy, Chemistry, Information Technology with several years (> 3) of experience in technical project management with proficiency in English. Pharmaceutical or related regulated industry will be a must

Preferred Profile:

  • Engineer or Pharmacist

Experience:

  • Minimum 3 years’ experience in a Pharmaceutical Quality Environment.
  • Industrial Processes : level 3 / GMP (GAMP 5 & 21CFR Part11) : level 3 / IT: level 3 / Quality Systems : level 3
  • Experience in the industry in the field of project management with experience in Quality management, IT compliance, or equivalent.

Skills:

  • Ability to demonstrate leadership 
  • Ability to demonstrate proficiency and thorough knowledge of computerize systems requirement defined by applicable European & US legislations, Health authorities and/or industry groups



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