Quality Assurance Senior Specialist / Responsible Person/ RPi
The Senior Quality Assurance Specialist is responsible for the implementation and maintenance of the quality management system (including QA distribution and commercial activities), proactively identifying and solving compliance issues in alignment with corporate quality functions and acting as a professional quality advisor to key stakeholders in the UK affiliate.
Act as the Responsible person to be named on the Wholesale Dealer’s License and
Act as the Responsible Person for Imports (RPi) as defined by MHRA to allow the import of QP-certified products into the UK.
KEY ACTIVITIES & RESPONSIBILITIES
- Maintenance of all relevant and necessary licenses
- Communication facilitation with UK Health Authorities and Department of Health and NHS
- Responsibility for implementation and maintenance of QMS and administration in compliance with the cGDP and applicable GxP directive regulation and company requirements
- Nonconformity Handling, CAPAs, and Internal Complaints oversight
- Change Control
- Suppliers and customers oversight ( Qualification process & Quality Agreements)
- Documentation management including electronic records oversight
- Archiving/ Controlled Records Management oversight
- Training Management oversight
- Regular Quality Management Review
- Planning and performing self-inspections and ensuring CAPAs are effective and completed in a timely manner;
- involvement and supporting audits and inspections
- Local QA Support for the maintenance of data integrity
- Decision process on Release/non-release of Returned goods
- Involvement in recall procedures and execution
- Regular reporting of QPIs and site performance as needed on a monthly basis
- Ensuring quality compliance of 3 PLs distribution providers
- Reporting products stock out situations
- Supporting and/ or participating in regional EMEA QA initiatives
KEY RELATIONSHIPS
Internal relationships
General Management
Commercial stakeholders
Distribution centres and manufacturing sites
RA team
PV team
Regional QA teams
External relationships
UK MHRA
UK Department of Health DASH
NHS
Wholesalers
EXPERIENCE
- 5 years of experience in the pharmaceutical industry, with solid knowledge and experience in quality and compliance for medicines (GxP) and medical devices ISO 13485 and/or ISO 9001
- Hands-on experience in implementing/managing quality systems in a GxP environment
- Fluent in English (oral and written)
- Ability to communicate proficiently with all levels of the organization and its clients
- Required to be a proactive, self-assured professional with high personal integrity and accountability
- Ability for some occasional (international) travel
