Your Responsibilities:
As a Qualification Expert will be responsible to prepare, execute and document the qualification activities on production equipment, infrastructures and utilities in a multi-national company.
The service is structured in operating units that focus on qualification activities to support manufacturing of OTC products.
Job Purpose:
Under the direct supervision of the Qualification Manager, the Qualification Expert will be responsible for:
- Qualification of existing systems of Nyon Sites production units following the annual qualification masterplan
- Qualifications and tests required on change requested to be made on systems
- Necessary support in terms of documentation, qualification and tests on new investment projects
-Potential Back up tasks of the Qualification Manager and support him/her in his/her day to day operations
Key Responsibilities:
- QUALIFICATION: Prepare, execute and document systems qualifications with excellence in order to ensure compliance of installed systems. Make sure good practices are followed in terms of qualification on engineering projects and continuous improvement projects. Ensure the qualification level matches the qualification masterplan of the site. Drive risk analysis. Apply Global Engineering Standards. Responsible for timely implementation of qualification tasks in line with operations constraints
- QUALIFICATION: Understanding of technical and IT systems used in GSK consumer HealthCare. Basic understanding of automation system. Knowledge in physical measurement principles. Reading and understanding of PID, material flow and technical drawings. Interpretation and use of calibration equipment when necessary.
- SUPPORT TO NYON SITE: Provide support during the Vertical Start-Up Management (VSUM) as well as afterwards during regular operations. Support PU liquids, SSOL, PCS and R&D of Nyon site in the follow-up of the qualified status of their equipments.
- LEAN methodologies deployment and benchmarking activities: Seek solutions outside the Nyon site (suppliers, other plants etc…), share best practices and external trends. May coordinate benchmarking activities, or seek new trends (equipment, process, technologies). Apply continuous improvement methods such as Lean, problem solving, 5S as well as OEE (overall equipment effectiveness) related methods such as SMED (single-digit minute exchange), TPM (Total productive Maintenance), when appropriate
- SAFETY: Role model all EHS GSK consumer HealthCare rules and behaviors (apply and promote).
- GMP: Respect all GMP standards. GMP knowledge and experience to support the requirements expected by Swissmedic, European union agencies and other regulatory bodies to assure that our products meet all cGMP requirements together with our operations and documentation system.
- French language is a must as most of the documentation will be written in French but English is also required at basic level
*LI-GSK
Why You?Basic qualifications:
Technical knowledge:
- Proven experience (minimum 5 years) in qualification in a Maintenance, QA or Qualification/Validation team. Successful qualification of production equipment, infrastructures or utilities.
- The qualification expert has to understand and challenge technical data.
Basic qualifications:
University or engineer Degree in Mechanical, electro-mechanical, chemical, quality or automation engineering.
Preferred qualifications:
- Analytical mind needed
- Continuous improvement mindset
- Able to build a cross functional network to address transversal need and constraints
- Result, value and performance oriented
- Rigorous documentation skills
Why GSK?:
GSK is one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
At GSK we provide a supportive working environment, and a range of development challenges and opportunities. We also offer competitive benefits and compensation packages designed to attract and to retain the very best. GSK
Contact information:
You may apply for this position online by selecting the Apply now button.