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Job Details

Senior Quality Engineer

Company: Hobson Prior
Location: North West of England
Reference: MO4346
Closing Date: 04 Aug 18
Type: Contract
Salary (£): On Application
Benefits: Dependent on Experience

Job Summary:

Part of the Quality team reporting into the Quality Manager, QC & QE. This role provides Quality Engineering support to site manufacturing processes by maintaining and developing the Quality System.

Requirements:

Part of the Quality team reporting into the Quality Manager, QC & QE. This role provides Quality Engineering support to site manufacturing processes by maintaining and developing the Quality System. This includes the procedures and records required for the development, validation and production of products and processes in order to assure the ongoing quality of products and maintain compliance with ISO 9000, ISO13485, FDA QSRs and the Medical Devices Directive. 

Duties & Responsibilities (leadership, people development, planning and execution) 

  • Perform monthly trending of all NCs that arise within designated production processes. 
  • Generate such data as is required for Dashboard reviews as they apply to designated production processes. 
  • Ensure all assigned quality actions are investigated, have causes identified and actions plans completed to the agreed schedule, regardless of source.
  • Perform Internal Audits to schedule and complete audit reports and effectiveness reviews. 
  • Lead investigations into product or process issues raised within designated production processes, identifying root cause and corrective action plans as required. 
  • Partner with Engineering team during the definition and introduction of new or improved processes, ensuring all validation, calibration, risk management and documentation activities are completed. 
  • Complete Periodic Validation Reviews and Process Monitoring & Control (Relating to ongoing process verification) 
  • Support operations and engineering teams to ensure that Preventive and Corrective Maintenance activities are completed to schedule. Ensure that Critical System Changes are raised for all applicable changes. 
  • Work with operations and engineering teams to ensure that process improvement activities including Lean Manufacturing activities are identified and introduced in a compliant manner. 
  • Quality Leader within assigned Value Stream 
  • Quality and Compliance Related Responsibilities 
  • Ensures that all activities are carried out in compliance with all regulations and laws governing business and quality operations. 
  • Responsible for ensuring compliance with all local, national, international and company regulations, policies and procedures for Health, Safety and Environmental compliance. 

Job Specific Competencies 

  • In depth knowledge of Good Manufacturing Practice. 
  • In depth knowledge of quality systems and techniques including ISO 13485 and FDA QSRs. 
  • Knowledge of Quality toolbox including FMEA, Mind-Map, Root cause investigations, Lean and Six Sigma tools & techniques. 
  • Computer literate. 
  • Basic Statistical knowledge to apply to operational improvements / investigations. 

GLP Competencies 

  • Ability to carry out structured problem solving and Credo based decision making. 
  • Ability to communicate effectively at all levels across the business. 
  • Ability to build productive relationships at all levels of the organization. 
  • Takes a determined approach to problem solving and to make informed decisions. 
  • Ability to make complex issues simple. 
  • Ability to manage and adapt to changes effectively. 
  • Identifies ways of doing things better and faster. 
  • Ability to listen effectively and remain open to other's ideas. 
  • Ability to express opinions and ideas, verbally and in writing. 

Education 

  • Minimum of degree in scientific discipline. 

Experience 

  • Minimum of 3 years in a quality, technical or manufacturing role in a regulated industry. 
  • Well-developed organisational skills with an ability to work independently. 
  • Working knowledge of ISO9001, ISO13485 and FDA Quality System Regulations an advantage. 

Personal Attributes 

  • Detail conscious 
  • Excellent time-management 
  • Good interpersonal skills 

Specific Technical Skills 

  • Focus on achievement and delivery of results 
  • Versatile – readily grasps technical detail outside own speciality 
  • Well organised, can cope with a number of competing projects and activities 

Essential 

  • Must have experience of working to International Quality Standards such as FDA and ISO. 
  • Use of Microsoft Office suite including Word and Excel for generating reports. 
  • Good written and verbal communication skills. 

Desirable 

  • Use of Microsoft Office suite including Project. 
  • Lean Manufacturing application

 

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Contact Information:

Address:  Hobson Prior International Ltd
Wellington Gate
7-9 Church Rd.
Tunbridge Wells
kent
TN1 1HT
England
Tel:  01892 612 612
Fax:  01892 612 613
Website:  Visit Our Web Site

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