职务描述
Opella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally.
Our mission: to bring health in people’s hands by making self-care as simple as it should be for over half a billion consumers worldwide.
At the core of this mission is our 100+ loved brands, our 11,000-strong global team, our 13 best-in-class manufacturing sites and four specialized science and innovation development centers.
Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan.
B Corp certified in multiple markets, we are active players in the journey towards healthier people and planet.
Find out more about our mission to bring health in your hands at
www.opella.com.
1. Quality management of the MAH business
Provide Quality oversight and quality support to Company, participant MAH Quality system establishment and maintenance.- CMO product quality overview including complete batch record review to ensure the product comply with the relevant regulatory and specification.
- Deviation and out-of-specification management, perform and coordinate with CMO to perform investigation. Review deviations, OOS investigations, CAPA plan and effectiveness. Monitoring of deviations / OOS / CAPAs trends.
- Complaints management with review of complaints investigation, CAPA plan and effectiveness review. Monitoring of complaints trend and initiating CAPA where required.
- Validation and qualification management, system establish, maintain and continuously improvement, including process validation, cleaning validation, transportation, holding time validation, facility, utility and equipment qualification etc.
- Review the validation protocol and report provided by CMO to ensure it comply with Opella Global quality’ requirement and GxP requirement.
- Product annual review management. Review the annual review report and perform the assessment and ensure the product quality is under control. Monitor the trends and define the action when required.
- Participant the routine management of self- inspection, third party audit.
- Perform the change control assessment and risk management as SME .
- As the delegation of QP to perform product release if necessary.
Quality Management of third-party manufacturers and suppliers
- Manage the Quality Due diligence, evaluation, selection, and approval of third-party manufacturers assigned.
- Provide Quality oversight and quality support to Company entities managing third party manufacturers in this region.
- Support the third-party audit plan for the EM CHC CHINA hub and request / allocate / perform the GxP audits per plan.
- Manage the review, discussion, and follow-up of CAPAs related to audit and to the ongoing management of products manufactured by the third-party for the Company.
- Support of product recall and return associated with EM CHC CHINA.
- Manage Quality aspects associated with termination activities with third-party manufacturers.
- Monitors and reports Quality KPIs. (Complaints, PQR, audit adherence to plan). Support the management of Quality Monitoring and Quality Review.
- Participate in quality monitoring and quality review of third-party manufacturers.
- Perform risk ranking of third-party manufacturers.
2. Quality Operations of EM CHC CHINA Entity
- Participate in continuous improvement / development of quality systems on an ongoing basis and assist in investigations, reviews, management, and co-ordination of Quality Systems and processes within the EM CHC CHINA entity and in collaboration with the Quality teams in full EM CHC AMEA & China entity, in line with Organizational, Global Quality, Regulatory Standards and Industry Best Practice.
- Participate in and manage the Quality observations and Self-inspection program for the EM CHC CHINA hub and the EM CHC AMEA & China entities with a key focus on continuous improvement and efficient compliance.
- Participate in the empowerment of the EM CHC CHINA hub Quality Managers / team members (as applicable) for operational quality decision making, without compromising the Quality System &/or Standards through implementation and adherence to and alignment with the Quality Documentation, Quality Systems Management and Quality Technical Support.
- Support the Quality Risk management in case of major / critical quality issue originating from third party manufacturers and raised by EM CHC CHINA. Coordinate and participate in quality risk meetings and prepare rapid quality notifications if required.
- Support the Quality business process owner for the EM CHC CHINA entity to manage and collaborate on new requirements, new Quality System projects (as example new computerized systems), gaps to existing and procedural updates.
- Support collection, consolidation, and preparation of the quality KPI’s (Key Performance Indicators) for EM CHC CHINA entity Monthly Quality Reports for reporting to regional Quality and EM CHC AMEA.
3. Quality Technical Support
- Contribute to the cross-functional working relationships of the team by participating in interactions between the EM CHC CHINA Quality team and key stakeholders including, Innovation, External contractors and third-parties, Health & Safety, R&D, Regulatory CMC etc.
- Assist in investigations, reviews, management, and co-ordination of Quality Systems within the EM CHC CHINA entity and provide quality oversight and support to third party manufacturers.
- Provide Technical advice and expertise with respect to product, CMO and quality system compliance.
- Manage and monitor completion to target of Annual Product Quality Review program across the EM CHC CHINA entity
- Manage the review of technical reports e.g. stability reports, process /process validation, transport qualification reports etc.
- Provide Quality support for transversal projects e.g. new product launch, site transfer or repatriation etc. as required
4. Others
- Any Ad Hoc activities as specified by the Reporting Manager
We Are Challengers.
We are dedicated to making self-care as simple as it should be. That starts with our culture. We are challengers by nature, and this is how we do things:
All In Together: We keep each other honest and have each other's backs.
Courageous: We break boundaries and take thoughtful risks with creativity.
Outcome-Obsessed: We are personally accountable, driving sustainable impact and results with integrity.
Radically Simple: We strive to make things simple for us and simple for consumers, as it should be.
Join us on our mission. Health. In your hands.