Quality Manager GDP Responsible Person CHC

Job description

About the opportunity

As Quality Manager / GDP Responsible Person Consumer Healthcare (CHC) you will fulfil a diverse and important position in the newly standalone CHC business of Sanofi. You will manage the implementation and maintenance of the Quality System (covering GDP, GSP and health-regulated activities) across the local Commercial organization. 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 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.

Working location is at Warehouse in Kyiv region, Boryspil district, village Velyka Oleksandrivka.

About growing with us

In this role you will:

·  Implement, manage and maintain the CHC Affiliate Quality Management System linked to GDP and GSP activities across the CHC commercial office, in compliance with CHC Global Quality Policy and standards and with local applicable regulatory requirements, including:
·  Quality Risk Management
·  CAPA to address deviations / non-conformities
·  Change Control opening, reviewing, assessing, closing (including subcontractors)
·  Measurement of Quality Performance Indicators and Management Review of Wholesaling activities
·  Maintain CHC Affiliate Quality Documentation Management System
·  Track GDP, GSP / Local Wholesale Regulation
·  Approve any subcontracted activities impacting GDP, GSP, this cover periodic auditing, qualification, process specification for subcontractors / suppliers / distributors / customers, ensure that quality-related clauses are in place in service agreements or technical quality agreements for all Third Parties of GDP, GSP and health-regulated activities for local Commercial organization
·  Lead and Manage CHC Affiliate GxP regulatory inspections related to Wholesale licensing, GDP and GSP processes, internal and external audits, self-inspections
·  Ensure Premises & Equipment, Systems (including GxP computerized systems and GxP spreadsheets) and Processes qualification / validation in GDP and GSP scope
·  Maintain own competence in GDP, GSP and Local Wholesale Regulation through regular training and perform appropriate trainings of all personnel involved in the distribution of medicinal products
·  Manage Complaints / Returns / Recalls
·  Ensure that adequate robust procedures are in place to manage any actual or potential falsified medicinal products that are identified in the supply chain
·  Ensure that personnel involved in GDP & GSP activities have a Job Description which includes responsibilities and accountabilities (signed by employee and manager & dated) and Training is being performed (including subcontractors)
·  Ensure that all the Wholesale distribution activities covered by the corresponding Wholesale Distribution License (WDL) are operated by the Commercial organization in full compliance with Ukrainian Licensing Conditions and GDP, GSP requirements
·  Perform local Market Batch Release / Disposition
·  Focus on the management of authorized activities and the accuracy and quality of records
·  Ensure that relevant customer complaints occurring in the distribution channels are dealt with effectively
·  Ensure quality oversight on local distributors (“Buy & sell CHC products” partners)
·  Manage notifications from and to local Health Authorities for CHC product related quality events in liaison with other CHC Affiliate Functions as appropriate
·  Ensure that any additional requirements imposed on certain CHC products by Ukrainian law are adhered to
·  Ensure that processes are in place in order to handle out of stock situations and associated communication to relevant parties, in coordination with other CHC Affiliate Functions (e.g. Regulatory Affairs, Supply Chain, Medical)

About you

Qualifications / Education & work experience

·  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 the Responsible Person role. Meets local regulations for nomination of Responsible Person
·  English and Ukrainian languages Fluent

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.