Quality Assurance Manager GCP

Location
Dublin (City), Leinster (IE)
Salary
Negotiable
Posted
05 May 2021
Closes
04 Jun 2021
Discipline
Quality
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

I am working on a New opportunity for a Quality Assurance Manager to join a young ambitious international biopharmaceutical company. 

 

If you are driven, ambitious and looking for an exciting career move then contact me to discuss further..

 

You will be a part  of the management team with overall responsibility for the Quality Management System.

 

 

 

Main Duties / Responsibilities:

 

  • Maintain and develop the Quality Management System in accordance with relevant regulatory requirements and business need.

 

 

  • Implement an effective Quality Assurance process, including internal and external audit programs, and ensure timely completion of audits.

 

 

  • Lead the quality oversight process on outsourced activities, which includes. 
  • Developing and maintaining Technical Agreements with vendors in line with relevant regulatory and business requirements

o Performance of onsite audits as required – vendors / clinical sites.

 

o Analysis and reporting of Key Performance Indicators (KPIs)

 

 

 

  • Oversee the effective documentation and tracking of QMS activities, including deviations and change controls, and the implementation of corrective actions. 

 

 

  • Provide quality leadership and support to operational teams, including the review of batch records, technical reports, and clinical trial protocols.

 

 

  • Manage the Documentation Control process, ensuring that policies and procedures are up to date, and available to all relevant parties.

 

 

What you need to succeed:

  • Ambition and ready for a new challenge in a fast-paced environment
  • Third level qualification in a scientific discipline
  • A minimum of 3 years GCP and GMP experience in the pharmaceutical or clinical industry 
  • QA auditing experience
  • Knowledge of relevant regulatory requirements
  • Excellent interpersonal, communication, and problem-solving skills.
  • Flexible in reacting to changing priorities in a dynamic business environment.
  • Ability to travel as required.

For confidential discussion and further details contact Tina at +353 1 2784701 or 087 6811990 or email your CV to tdunne@thornshaw.com

Thornshaw Scientific is a division of the CPL Group www.thornshaw.com

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