Responsible Person - Surbiton, United Kingdom - Finiten

Finiten

Verified Company

Surbiton, United Kingdom

2 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

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 selfinspections 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/nonrelease 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, selfassured professional with high personal integrity and accountability
Ability for some occasional (international) travel

Job Types:
Full-time, Permanent

Pay:
£65,000.00-£70,000.00 per year

Benefits: