We use cookies to improve your experience on this website.

Quality Systems Improvement Lead

U268

Quality Systems Improvement Lead

Category:
Quality
Location:
United Kingdom
Date Posted:
16/07/2019
Days Remaining:
10
Employment Type:
Permanent full-time

We are currently recruiting, on behalf of our client who are a global pharmaceutical manufacturer based, for a Quality Systems Improvement Lead.

 

Purpose of the role

To ensure the Quality Management System operation:

Enables the manufacture of medicinal products in accordance with current national and international applicable legislation and regulatory expectations, relevant standards and guidelines and the relevant Manufacturing and Marketing Authorisations;

Identifies and manages risks to the business through application of Quality Risk Management, effective Change Management and Regulatory Intelligence processes;

Remains in a State of Control and opportunities for improvement are continuously identified and acted upon.

Duties and responsibilities

Provides visibility and awareness of changes in legislation, guidelines and pharmacopoeias and co-ordinates the implementation of such changes as required.

Maintains the Site Risk Register and ensures effective linkages in relation to Quality Risk Management are in place between key QMS elements such as Change Control, Validation, Non-conformances/Deviations.

Ensures appropriate Corrective and/or Preventive Actions are identified to eliminate, reduce or mitigate risks.

Supports the implementation of the site Audit Readiness Program.

Supports hosting of external inspections and customers audits by participating in pre-audit, audit execution and audit response activities.

Co-ordinates data collection and analysis for selected Key Performance Indicators that feed into the monthly Operational Review and Management Review meetings.

Co-ordinates writing of Annual Product Quality Review reports and ensures appropriate Corrective and/or Preventive Actions are identified as required.

Proactively identifies and implements improvement opportunities within the Quality Systems group and in the wider business.

 

 

 

 

 

Back to top