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 4 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.
As a globally certified B Corp company, we are active players in the journey towards healthier people and planet. Find out more about our mission at www.opella.com.
Our mission is to bring health in people’s hands by making self- care as simple as it should be. For half a billion consumers worldwide – and counting.
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.
About the Role:
Contributes to the implementation and management of Quality Systems on one/several specific domains, by providing technical support to QS Specialists and users:
- In charge of the work relating to product management.
- Compliance with HSE rules, policies.
- Join to APU activities, inspire Challenger Mindset spirit.
- Supporting other works of QA departments to ensure that the manufacturing process of all products comply with GMP requirements and with specific Sanofi requirements outlined in the company Directives and Guidelines.
- Seader or support implementation and monitoring the work related to the projects.
- Support implementation and monitoring QA system- related work.
Key Accountabilities:
Product management:
- Issue, check and arrange batch record, analytical sheet.
- Review batch manufacturing record and FP analysis record prior to the batch release decision of responsible or delegated person.
- Release the batch on system and extract FG CoA.
- Check the checklist and sign on the part of certification for batch release/ rejection when delegated, ensure that each batch of medicinal product has been manufactured and checked in compliance with the laws in force in that country and in accordance with the requirements of the marketing authorization.
- Manage deviation and ILI: Investigate and follow deviation and ILI related RMs and assigned product.
- Tracking progress implementing of the corrective and preventive action related to quality to ensure appropriate and timely improvements.
- Manage the change control system for QA solid team: make sure change control is approved before application, perform and follow up blocking works, make sure blocking works are replied before next step, follow close change control as monthly planning.
- Manage customer complaint: investigate and response assigned product complaint.
- Responsibility of Administrator for assigned equipment, system and performed assigned periodic audit trail.
- Perform annual product quality review (PQR) for assigned product, follow up the performance of CAPAs.
- Support to establish Validation Master Plan and monitor the implementation of the assigned work schedule.
- Perform qualification (qualification perfomance, process qualification preformance, cleaning process, transportation validation and support to equipment qualification): prepare protocol, monitor, acess and report the result, follow up the proposal from validation/ qualification result.
System management:
- Prepare, update SOPs relating to the field of charge, check the compliance with local and global requirement.
- Check the compatible between reality and requirement of GMP, GLP, GSP, Halal. Participate GMP training activities.
- Perform periodic reports: monthly report, quarterly report, Collect data, process and report related to quality upon request.
- Involve to prepare the quality agreement for assigned supplier.
- Perform GMP and Halal self inspection as assigned.
- Supplier audits, monitor the performance of supplier’s CAPA.
- Participate activities related to regulatory audits/ inspections.
Project:
- Coordinate with relevant departments and supplier to define planning, perform, monitoring and report on projects related to simplification, energy saving, cost reduction (C2W, I2W activities, backup source of RMs and PMs) and environmental protection.
APU activities:
- Participate and coordinate with relevant departments for APU activities.
Others:
- Proactive in simplification all quality related activities.
- Report to the appropriate management the cases not complied with the standards, with the GxP requirements and regulations.
- Support other activities of department when necessary.
HSE
- Strictly follow and remind colleague to follow the HSE requirement.
