Quality Manager

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life‑saving and life‑enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun.

A name started our story. How will yours help write our future?

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.

As a member of the Cornwall Management Team (Senior Leadership), the core objective of this position is to provide the following:

• Direct and co‑coordinate the Plant Quality Assurance Department to assist manufacturing to achieve high levels of Quality.
• To develop or agree with Manufacturing, as appropriate, factory and QC Processes and Controls.
• To establish and maintain the Plant Quality Assurance Manual based on the Quality Policy and the requirements of ISO 9001 and GMP Guidelines for the Pharmaceutical Industry.

Overall responsible for the following resources:

• Quality Assurance

• It is the Quality Policy of West Pharmaceutical Services Cornwall Ltd, to plan and control its activities to ensure that all products and services conform to the requirements of our customers and provide full customer satisfaction. The principle objective is to supply products that are cost effective without prejudice to the required standard of performance, reliability and quality. Accountability for the implementation of this Policy is delegated through this Job specification.
  
  All employees must conduct activities in accordance with the company Quality Policies/Procedures at all times.
• Comply with company cGMP regulations.
• Accurate recording of documentation and data as required.
• Be responsible for defect recognition.
• Supports preparation of the QA part of the European Business Plan.
• Prepares monthly statistical reports against the Key Performance Indicators and report to the VP QA Europe.
• Handle all customer notifications and respond to the customer in a timely manner.
• The approval of customer specifications.
• Testing and release of raw and auxiliary materials.
• The auditing of suppliers and issue of delivery specifications in co‑operation with EQA.
• Authorise all changes within the change management system.
• To manage and control all CAPAs.
• Supports the approval of qualification of new equipment and/or validation of new processes.
• Assists all departments regarding quality aspects.
• Supports customer relations by assisting the plant to meet customer standard by aiding in problem solving efforts.
• To co‑coordinate the Quality Management System.
• Responsible for 5S audits.
• Responsible for customer specifications.

• Lead by example and get involved to ensure the overall implementation of the Safety Leadership Statement and to maintain its on‑going effectiveness. Involvement includes allocation of time, budget, staffing, training, priority setting, accountability, visibility and follow up etc.
• Hold the overall responsibility for safety, health and welfare at work of employees, visitors and contractors. Responsibility to ensure that appropriate resources are made available to support the Health and Safety activities on site.
• Create a safe and healthy workplace where employees are motivated and energized to do their best each day and return safely to their families after work.
• Have a sufficient number of resources in place: HSE Leader, plus Safety Representatives within each department, Occupational Health Physician (where legally required), First Aiders, Emergency Response Resources.…