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Quality Assurance Manager GCP

Employer
Thornshaw Recruitment
Location
Dublin (City), Leinster (IE)
Salary
Negotiable
Start date
28 May 2021
Closing date
24 Jun 2021

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Discipline
Quality
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

Job Details

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

Company

thornshaw-title

Thornshaw Scientific Recruitment was first established in 1999 and since then has become a leader in Scientific recruitment.  In 2005 we partnered with Cpl Resources, one of Europe’s most successful recruitment companies.

Our wealth of experience in specialised recruitment allows us to offer the right solution to each employer, whatever their recruitment requirements.

Over the years we have developed strong relationships with our clients in the market and we pride ourselves on our repeat business from clients.

Our Industries

We are a global provider and have been providing a reputable recruitment service to the Biotech, Pharmaceutical, Clinical Research, Medical Device, Engineering and Healthcare industries for over 20 years. 

Our Specialities

Clinical Research, Regulatory Affairs, Quality Assurance, Medical Affairs, Pharmacovigilance, Biostatistics, QC, Validation.

Our Mission

thornshaw-ourmission

For further details on our services contact Tina at +353 1 2784701 or email tdunne@thornshaw.com

 

Company info
Website

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