Job Description
ROLE OVERVIEW
We are currently supporting a Healthcare Supply Chain & Logistics company seeking a Quality Manager and RP to join their team in Leicestershire. This is a fantastic role for those looking to make a significant impact within a dynamic and regulatory-driven environment.
As the Quality Manager, you will be responsible for ensuring compliance with the company's Quality Management System and regulatory requirements set out by the MHRA and Home Office.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Quality Manager and RP will be varied however the key duties and responsibilities are as follows:
1. Ensuring the Quality Management System operates consistently and effectively, including Change Control, deviation, CAPA, and self-inspection.
2. Ensuring compliance with procedures, ISO 9001, ISO 13485, and GxP legislation and regulatory expectations.
3. Defining standards for quality activities, measuring and reporting results to the Senior Quality Management Team.
4. Providing quality oversight and input into the Employee Training Program, including training, coaching, and mentoring the on-site quality team.
ROLE REQUIREMENTS:
To be successful in your application to this exciting role as the Quality Manager and RP we are looking to identify the following on your profile and past history:
1. Relevant degree in a Scientific related field. Ideally a Qualified RP but training can be provided if not.
2. Proven industry experience in a Quality or Regulatory environment within the pharmaceutical or medical devices industries.
3. A working knowledge and practical experience with ISO 9001 quality systems, Root Cause Analysis techniques, and Good Distribution Practice legislation.
Key Words: Quality Manager / Government Contracts / Quality Management System / MHRA / Home Office / GDP/ GxP / ISO 9001 / ISO 13485 / Pharmaceutical / Medical Devices / Regulatory Compliance/ RP / Responsible Person
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the Life Science sectors, combining recruitment expertise with scientific knowledge to help you advance your career.