Description
Main PurposeEnsure the organisations audit programme (internal and external) is controlled and managed as per regulatory requirements and to internal organisations standards.Key Accountabilities
- Ensures systems are in place to issue, control, periodically review obsolete and archive all quality relevant site documentation
- Is the subject matter expert on site electronic quality systems - Mango, Trackwise and eDMS as appropriate
- Ensures the site complaint and deviation investigation system work effectively to pre-defined timelines
- Supports and supervises risk analysis and assessments and acts as moderator as necessary
- In conjunction with the Quality Assurance Manager set the quality systems standards strategy to ensure licensed products and food supplements are manufactured in compliance with regulatory requirements
- Work with the QC Manager to ensure QC systems are integrated in to the site quality systems
- Generates the site Validation Policy and acts as a quality approve of validation documentation including computer validation and ensures electronic systems are validated according to organisation and GAMP requirements
- Support business in GxP and internal audits
- Develops and reports KPIs to measure improving performance of the quality assurance system
- Develops actions together with the business for improving KPIs and general standards
- Supports, classifies and supervises change control
- Supports, assesses and closes deviations
- Provides and facilitates training on quality
- Supports NPD and extensions to current product portfolios where appropriate
Qualifications/Knowledge & Skills
(Essential)
- Science Degree or relevant experience
- Previous experience in a Quality Assurance Management role
- Leadership skills with ability to influence
- Validation experience in the Pharma industry
- Confident user of IT systems
- GAMP implementation experience
- Excellent communication skills
- Knowledge of quality management systems
- Previous experience of working in a Liquids manufacturing facility
- Broad understanding of manufacturing operations business
- Understanding of QC testing operations
- QA systems audit experience
- Well developed risk assessment skills
- An understanding of the legal requirements, rules and guidance covering the manufacture of Pharmaceutical products in Europe
- Assertive decision maker
If you are interested in this position and have the relevant experience please contact me asap on .
To find out more about Real please visit www.realstaffing.com