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Job Details

Process Engineer (Deviations & CI) - Permanent

Company: Novartis
Location: Ireland Cork City
Reference: 232329BR
Closing Date: 20 Mar 18
Type: Full Time
Salary (£): On Application
Benefits:

Job Summary:

Job Purpose Support Production Management in improving the efficiency, quality and safety of the Manufacturing environment. Provide support to Manufacturing department to investigate deviations, identify root cause and determine corrective and preventive actions to be taken. Work with cross functional department team to prevent recurring deviations. Drive process improvements which will prevent the occurrence of deviations. ...

Requirements:

Job Purpose
Support Production Management in improving the efficiency, quality and safety of the Manufacturing environment.
Provide support to Manufacturing department to investigate deviations, identify root cause and determine corrective and preventive actions to be taken. Work with cross functional department team to prevent recurring deviations. Drive process improvements which will prevent the occurrence of deviations. Create and maintain metrics governing deviation rates and in particular recurring deviation metrics. Researches and instigates new projects which lead to process/ product improvements. Must also demonstrate analytical skills in problem solving.
Major Accountabilities
1. Perform manufacturing deviation investigations and root cause analysis within the agreed investigation timelines. Draft reports to document related activities.
2. Use of problem solving tools to perform thorough investigation of non-conforming events. Ensure that the appropriate root cause analysis tools are used when leading NCE investigations if applicable.
3. Create, maintain and present metrics governing deviations.
4. Monitor non-conformance trends for CAPA escalation.
5. Create and drive change controls required for effective CAPA implementation or CIP projects.
6. Draft and route standard Operating Procedures as required. Identification and training of new Lead investigators.
7. Responsible for driving effective CAPAs for compliance actions within the agreed timelines.
8. Responsible for driving effective CAPAs for internal and external audit findings within the agreed timelines.
9. Drive Lean Manufacturing and CIP projects to conclusion.
10. Ensure continual Quality System compliance by adherence to established and evolving Alcon and Novartis QS requirements.
Key Performance Indicators/Measures of Success
? Reduction in rate of recurring deviations.
? Presentation of key metrics weekly/monthly to senior management.
? Effective CAPA implementation.
? Completion of assigned CIP projects.

Minimum requirements

Job Dimensions
Number of associates: N/A
Specific Position knowledge/skills/abilities:
? Knowledge of Quality Systems regulations including ISO13485.
? Strong technical abilities.
? Ability to work on own initiative and as part of a team.
? Excellent problem solving skills and competence on all Microsoft office applications.
? Ability to determine, influence and action appropriate corrective and/or preventive action.
? Report writing expertise, excellent communication skills and highly developed people skills.
? Knowledge of statistical methods.
Ideal Background
Education
Minimum: Bachelor degree in Engineering/ Physics or related discipline
Preferred: Masters/ PhD degree in Engineering/ Physics or related discipline
Alternative combination:
Experience
Minimum: 3 - 5 years working at Engineer level within a regulated or medical device environment.
Preferred: 5+ years’ experience at Engineer or Senior Engineer level within a regulated or medical device environment.
Alternative combination: N/A

Apply for this job: Process Engineer (Deviations & CI) - Permanent

Contact Information:

Address:  Novartis Pharmaceuticals UK Limited
Frimley Business Park
Camberley
Surrey
GU16 7SR
England
Tel:  +44 (0)1276 692255
Fax:  +44 (0)1276 692508
Website:  Visit Our Web Site

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