Quality Manager GDP Responsible Person CHC

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, No Spa, Guttalax, Enterogermina, Essentiale, Magne-B6 and Lasolvan.

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.

About The Job

With the responsibilities of Qualified Person and GDP Responsible Person Consumer Healthcare (CHC) you will fulfil a diverse and important position in the newly standalone CHC business of Opella. You will manage the implementation and maintenance of the Quality Management System (covering import of medicines, GDP, GSP and health-regulated activities) at the warehouse - No. 1 Opella Healthcare Ukraine, located 9, Boryspilska str., Velyka Oleksandrivka vil., Boryspil district, Kyiv reg., 08320 Ukraine. You will secure delivery of safe, efficient, quality CHC products, information & services to ensure patients/customers safety and act as Quality Business partner to support business priorities. As Qualified Person and GDP Responsible Person, you will ensure GDP and GSP compliance of wholesale distribution activities and finally you will act as a focal point of contact in front of the Competent Authorities for any CHC product quality / technical, GDP and GSP-related matter.

Main Responsibilities

• Implement, manage and maintain the CHC Affiliate Quality Management System at the Warehouse No. 1 in line with CHC Global Quality Policy, standards and local regulations, including Quality Risk Management, CAPA and Change Control (incl. subcontractors).
• Measure Quality KPIs, perform Management Reviews and maintain the Quality Documentation System..
• Lead and manage GxP inspections (Import and Wholesale licensing, GDP/GSP), internal/external audits and self-inspections. Ensure qualification/validation of Premises, Equipment, Systems (incl. GxP IT) and Processes.
• Maintain own competence and provide GxP training to all involved personnel at the Warehouse. Ensure Job Descriptions and training compliance (incl. subcontractors).
• Manage Deviations, Complaints, Returns, Recalls and ensure procedures for falsified medicinal products. Perform local Market Batch Release / Disposition and ensure accurate, compliant records.
• Ensure compliance with Import and Wholesale Distribution License requirements and Ukrainian Licensing Conditions. Oversee customer complaints in distribution channels and quality oversight of local distributors.
• Manage notifications with Health Authorities for product-related quality events. Ensure adherence to additional Ukrainian product requirements and processes for out-of-stock management in coordination with relevant CHC functions.
  
  

About You

• Scientific degree (Pharmacy degree is a mandatory with the document of higher education not lower than the second (master's) level in the specialty "Pharmacy", a certificate of pharmacist. specialist, issued by the institution of postgraduate education, or a certificate of assignment (confirmation) of the relevant qualification category)
• Experience of RP desired – in the specialty "Pharmacy" not less than two years, responsible for the quality assurance system of medicines during wholesale trade
• Trained on external GDP and GSP courses
• Solid experience in GxP particularly GDP and GMP areas & other Health regulation applicable in Pharmaceutical Industry
• Able to demonstrate continuous professional development in Quality Manager role. Meets local regulations for nomination of Qualified/ GDP Responsible Person
• English and Ukrainian languages Fluent
  
  

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.

www.opella.com/en/careers