Your Responsibilities:
As a Quality Systems Specialist – QMS Champion, you will have responsibility to:
- ensure that the QMS (Quality Management System) is being implemented and used correctly on site. The role will involve working with all grades and departments on site as well as liaising with the Global Quality organization.
- ensure that process to define and escalate risk is in place and in use as being Risk Management Process Owner (RMPO)
- ensure that KPIs are collected, analyzed and escalated to Site Quality Council (SQC)
- ensure process of Change Control, Deviation, CAPA, Laboratory Investigation and compliance are in place and aligned with QMS
- ensure Quality Alert / Quality Bulletin (QA/QB) are assessed and managed at site level
- be QA associate for Learning department
These responsibilities include some of the following:
1 – QMS Champion:
- Ensure that the site is operating with the full intent of the QMS
- Ensure that a subject matter expert is define for each Global Quality Policy and Global Quality Management Process
- Work with the subject matter experts on site to ensure that Gap Analysis, Risk Assessment are conducted and actions plan provided to remediate identified risk.
- Monitor and report the overall effectiveness of QMS implementation
- Ensure that the site is implementing updates in-line with the intent of the QMS
- Be the Subject Matter Expert for the QMS on site and during internal audit, customer audit and health authority inspections
2 – Risk Management Process Owner (RMPO):
- Ensure deployment of Risk Process on site
- Lead local process to escalate risk to Site RMCB and be the representative for EU RMCB
- Be the first level of support with the Risk Management System
- Be the Subject Matter Expert for the RMS on site and during internal audit, customer audit and health authority inspections
3 – Quality Systems:
- Collect and review KPIs for SQC and Quality Dashboard
- Ensure Quality System processes (Change Control, Deviation, CAPA, Laboratory Investigation, compliance) are in place and aligned with QMS requirements
- Review QA /QB, make assessment and manage action plan at site level
- Be the Subject Matter Expert for the Quality systems topics on site and during internal audit, customer audit and health authority inspections
4 – GMP and HSE
- Respect all GxP standards and HSE requirements at Nyon Plant
- Ensure associates respect local GMP and HSE requirements and escalate any significant issue observed
- Create and/or update any document related to the responsibility of the role
Why You?
Basic qualifications:
. Minimum 5 years of experience in the pharmaceutical industry within the quality assurance function and / or production function
. Proven process understanding in pharmaceutical industry (GMP regulation, Quality Systems, Bulk Manufacturing and Packaging Operations)
. Good interpersonal and leadership skills
. Safety, Quality and Results oriented
Preferred qualifications:
. Fluency in French and English
. Good knowledge of GMP and regulatory expectations
. Good knowledge of Quality Management Systems
. Excellent communication skills
. Experienced in working in a Pharmaceutical Manufacturing environment
. Ability to work in transversal organization and influence key decision makers
. Role model in GxP, HSE and GSK values expectation
Why GSK?:
Our Consumer Healthcare business develops and markets products in Wellness, Oral health, Nutrition and Skin health categories. Our seven global power brands – Otrivin, Panadol, parodontax, Poligrip, Sensodyne, Theraflu and Voltaren, include some of the most trusted and best-selling brands in the world.
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Contact information:
You may apply for this position online by selecting the Apply now button.