QA ecompliance Expert
- GlaxoSmithKline Plc Switzerland
- Vaud (La Côte)
- Date de publication
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.
- 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.
- 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
- Engineer or Pharmacist
- 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.
- 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