Your Responsibilities:
Oversight of QA Suppliers activities. This position serves as quality interface and key player in relationship between Nyon plant and suppliers or 3rd parties/service providers. This position is involved in relevant QA supplier activities: documentation (QAA, PRS, SRS, Approval Form, Supplier Monitoring, etc…), audits requests, escalation to the Global Supplier Quality Operation and complaints handling for suppliers (raw materials, packaging materials, consumables) & 3rd parties/services providers from a quality point of view for the purpose to guaranty conformity with GMP and GSK requirements.
This position will support Nyon plant supplier & 3rd parties/services providers qualification process, self-inspection program and will be involved in external inspections/audits hosted by the site.
These responsibilities include some of the following:
1/ SUPPLIERS & 3rd PARTIES/SERVICE PROVIDERS QUALITY OVERSIGHT
- Suppliers and 3rd parties/service providers approval process, documentation management and monitoring: Issue and maintain up to date Quality Agreements, ensure the supply of the current technical specification to the supplier (PRS) or to the service providers (SRS), management of the QIR, maintain/update the list of approved suppliers & 3rd parties/service providers and participate to supplier monitoring process
- Perform Quality Risk analysis for suppliers (Raw materials, packaging material, consumables) and 3rd parties/service providers
- Manage changes related to suppliers & 3rd parties/service providers (Supplier notification, User /regulatory requirements, unsatisfactory audits outcome…) as QA Associate
- Provide support to the Audit team in preparation to the annual supplier audit program, liaising with auditors for supplier information exchange and follow program completion
- Provide to affiliate and regulatory department all necessary support and documentation as per request
- Point of contact with Global Supplier Quality Organization
- Participate to the annual program for QA supplier deliverables (QAA, PRS, Supplier monitoring, etc …) and ensure completion as per the plan.
2/ SUPPLIERS & 3rd PARTIES/SERVICE PROVIDERS COMPLAINTS MANAGEMENT
- Follow-up with supplier on complaints related with materials (raw materials, packaging materials, consumables and 3rd parties/service providers)
- Ensure that system and organization is in place for collecting information / samples and complaints follow-up until fully solved and CAPA implementation at supplier (including CAPA effectiveness check)
- Participate to escalation process
3/ DEPARTEMENT ACTIVITIES
- Author and review Standard Operating Procedures related to QA supplier activity, as needed
- Periodically report KPIs for QA Suppliers activity
- Ensure that all records (Deviations, CC, CAPAs etc…) in which QA supplier oversight is involved is completed appropriately according to local SOP and on time
- Participate to self-inspection as per plan
- Support external inspections/audits on site
4/ GMP & HSE
- Respect all GMP standards and HSE requirements at Nyon plant and escalate any significant issue observed
- GMP knowledge and experience to support the requirements expected by Swissmedic, European union agencies and other regulatory bodies to ensure that our products meet all cGMP requirements together with our operations and documentation system.
Why You?
Basic qualifications:
• Minimum of 5 years industry experience, including a minimum of 2 years full-time supplier related activities (Quality Agreement writing, auditing, Supplier complaints management…)
• Use of risk management tool and standard quality tool (Fishbone, 5Why, FMEA, etc …)
• Working knowledge of regulatory agency requirements; US FDA, Swissmedic, EMEA, MHRA, WHO, ANVISA, ICH, ISO, PIC/S as well as others is required.
• Experience in international & multidisciplinary environments
• Willing to travel worldwide; sometimes at short notice: travel time up to 5 %
Preferred qualifications:
• Good interpersonal and leadership skills
• Safety, Quality, Result and Customer oriented
• Fluent (oral and written) in French and English
• Good communication & negociation skills
• Strong abilities for technical writing
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.
*LI-GSK
Contact information:
You may apply for this position online by selecting the Apply now button.