Title:  Quality Manager

Job Summary

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

• • Direct and co-ordinate 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.

Essential Duties and Responsibilities

Overall responsible for the following resources:

• • Quality Assurance
    
    

General

• 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-ordinate the Quality Management System.
• Responsible for 5S audits.
• Responsible for customer specifications.

Safety

• 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. Provide sufficient time for them to be effective and ensure back-up plan are in place to ensure daily work is covered in case of absence.
• Support the Plant Health and Safety Committee and ensure it is actively involved in discussions, planning, decisions and actions regarding health and safety at work.
• Manage and conduct work activities in such a way as to ensure the safety, health and welfare at work of the employees.
• Manage work activities in such a way as to prevent behavior, putting employees at risk.
• Establish a performance feedback and reward systems to hold people accountable for safety and to recognize/reward safe behaviors.
• Establish a site discipline/reward system which includes compliance with Safety expectations and behaviors. Ensure discipline is used to correct repeated unsafe Safety behaviors as appropriate.
• Ensure that employees are not subject to retaliation if they report safety issues within the site or raise concerns through West’s Compliance and Ethics Helpline.
• Ensure workers receive at regular intervals health surveillance appropriate to the health and safety risks they incur at work. Health surveillance shall be introduced in accordance with national law and / or practices.
• Establish comprehensive HSE Objectives/Goals/Targets/Plans, which are documented, measured, and communicated and which are consistent with the Corporate HSE Programs, and regional/global targets.
• Ensure each department has defined departmental goals and actions plans which are consistent with the site targets. Define goals and KPI’s (leading and lagging metrics) which are cascaded down through the organization.
• Without diminishing the overall responsibility of the Managing Director, he/she shall delegate specific responsibilities of the day-to-day safety management functions to other leaders.

Each employee has the following responsibilities:

• Take reasonable care for their own safety, health and welfare and that of any other person, who may be affected by his/her acts or omissions while at work.
• Work in a safe manner and stay alert, in order to avoid injury to themselves or other employees and avoid damage to the company’s equipment and property.
• Follow all safety rules and requirements and provide feedback to co-workers working unsafely.
• Use any personal protective equipment or clothing, suitable appliance, equipment or other means for securing his/her safety, health and welfare while at work.
• They shall not perform a job that for they were not trained to perform and they shall inform their supervisor in this case. 
• Partner with management on all the provisions taken by West to ensure the safety, health and welfare of its employees.
• SEE-DO-SAY Something: Respond to unsafe conditions, unsafe acts and near misses. Apply mitigation measures, and report to supervisor.
• Stop Think Act: Discuss problems openly with colleagues and leaders before taking action in a non-routine situation.
• Employees will not intentionally or recklessly interfere with or misuse any appliance, protective clothing, equipment or other means provided.
• Each employee will attend and follow training required by West.
• Employees shall not be under the influence of intoxicating substances such as alcohol or drugs and inform their supervisor of a disease, illness or prescribed medication that may add to risk.

Additional Responsbilities

Procedural Adherence

• Undertake all necessary training and re-training to be able to perform all aspects of the job.
• Adhere to the Company Ethic’s and Compliance Policies.
• Compliance with all Quality, HS&E and HR procedures.
  
  

Cost

• Measure and control functional costs and resources within agreed budgets to ensure the business is fully supported.
• Approve expenditure in line with authorisation level/responsibility.
• Support annual budget process.
  
  

Delivery

• Measure and control all Departmental resources to ensure that all are effectively and efficiently utilised to fully satisfy the core objectives.
  
  

People

• Define departmental objectives in line with business goals.
• Responsible for managing departmental time management ie T&A, RTW’s, Overtime, holidays and absence.
• Define functional training requirements and ensure that the team members are trained.
• Responsible for managing and measuring all the department individuals’ performance via the appraisal and disciplinary system’s.
• Responsible for departmental communication, team meetings and 1:1’s.
• Lead and manage the functional team in a fair and consistent manner.

Education

• • Degree in Chemistry or Science related
  • Six Sigma Green/Black Belt is desirable but not essential

Work Experience

• Minimum 5 years experience owning QA management system
• Strong Team Management & Leadership Skills (Minimum 3 years experience)
• Lead Audit experience
• SAP experience is desirable
• Experience with Bespak cels is desirable

Preferred Knowledge, Skills and Abilities

• Understanding of medical devices and knowledge of ISO standards 9001 + 13485 is a distinct advantage 

Travel Requirements

Additional Requirements

• To carry out other duties as may be required from time to time by your line manager.
• Ensure functional legislative compliance.
• Provide cover for other roles for which you are trained, as required.
• Measure, control and improve performance metrics.
• Lead and participate in project management.
• Responsible for driving continuous improvements through the use of lean sigma tools.
• Report any problems or irregularities which are outside your control to your line manager or other appropriate person.

Shift

Working Hours: 8am - 4pm (36 hour week)