Strategic Quality Lead, Qualified Person
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Job Location:
Central Bedfordshire - UK
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
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Job Description:
Job Summary
The Healthcare Quality Assurance (QA) Strategic Quality Lead and Qualified Person (QP) is responsible for the oversight of the Marken and Polar Speed Quality Management System (QMS) Standard Operating Procedures (SOPs) processes and policies required to manage and control storage distribution and production facility. With regional oversight support the GMP depots and practice quality requirements and meet Marken and Polar Speed our clients and regulatory agency expectations.
Responsibilities:
Ensure that any activity (storage additional labelling quality control release distribution returns rejects and destructions related to investigational medicinal products and starting materials is performed in compliance with European and regional regulations and good manufacturing/distribution practices by means of operating an effective QA system.
QP certification of pharmaceutical clinical trial materials in accordance with IMPDs PSFs and EU GMPs as well as taking any other QP responsibility as per GMP guidelines for Polar Speeds depot in Leighton Buzzard.
Support the head of production for the important IMPs in your area of expertise and for Marken in house manufacturing as necessary.
Host regulatory inspections and manage the regulatory audit report responses.
Liaise with all clients on all QP matters.
Prepare an external audit programme and perform audits of external service providers as part of the vendor selection process or of the clients supply chain as required to meet personal knowledge requirements for QP certification.
Provide Quality leadership and oversight of the QP team to ensure consistent implementation o and compliance to the Marken and Polar Speed Quality Management System at all locations in the assigned region.
Supports growth of new and expanded facilities clients and services.
Communicate and maintain the Marken and Polar Speed Quality plan.
Ensure targets are achieved through effective quality performance monitoring measurement and analysis and reporting. This may include working specific hours and change in shift pattern.
Qualifications:
Bachelors degree or International equivalent in Sciences- Required
Degree qualified within a scientific related discipline and recognised as a Qualified Person in accordance with Regulation 36 of the Human Medicines Regulations 2012 (SI 2012/1916)
Pharmaceutical healthcare or food industry experience - Preferred
10 plus years o relevant experience working in a Qualified Person role within GSP/GMP/GDP regulated position
Deep knowledge and understanding of GMPGDP AND ISO Compliance
ASQ or ISO Certification preferred
Employee Type:
UPS is committed to providing a workplace free of discrimination harassment and retaliation.
About Company
United Parcel Service (NYSE: UPS) is a global leader in logistics, offering a broad range of solutions including the transportation of packages and freight, the facilitation of international trade, and the deployment of advanced technology to manage the world of business more efficien ... View more
