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Mylan

QA Manager

Mylan

  • Dublin
  • Negotiable
  • Permanent full-time
  • Updated 06/02/2013
  • HR
this job is expired
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Description

QA Manager, QP Qualified.

 

QA Manager

Reporting to:             Quality Director

Main Objectives:

  • The QA Manager is responsible for managing, reviewing and developing GMP systems on site in accordance with cGMP principals.
  • The position requires excellent inter-personal skills to assist in liaison with other departments within the site in order to support quality requirements.

 

Main Duties:

  • Responsible for review, investigation and close-out of product complaints in a timely manner.
  • To publish and maintain the internal audit schedule.  To ensure the execution of this calendar of events including reporting and close out of all issues.
  • To administer and maintain the Change Control & Deviation systems in accordance with the relevant SOPs at Gerard Laboratories to ensure a timely close-out.
  • Responsible for control of Approved Supplier Listings.
  •  Manage the Quality System for controlled drugs on site.
  •  Report Quality Defect Reports to the IMB and drive investigations for same.
  • To ensure that up-to-date Technical Agreements are in place where Gerard Laboratories is the contract giver.
  • To administer the SOP system for the entire facility.
  • To coordinate and participate in third party audits (both customer and Regulatory) of Gerard Laboratories.
  • Co-ordinate and develop GMP training on site.
  • To ensure that the systems with a GMP impact are maintained as per written procedures.
  • To ensure that good GMP standards are maintained at all times.
  • To adhere to all company and legislative health, safety and environmental requirements.
  • Any other duties as assigned by the Quality Director.

 

  • Requirements
  • Excellent interpersonal skills
  • Minimum of a Bachelor Degree in Science or related pharmaceutical discipline.
  • At least 6 years pharmaceutical quality experience ideally with previous QA management experience.
  • Experience in a high volume environment.
  • QP qualification.
  •  Previous experience in leading a Health Authority  inspection would be an advantage.
  • Proven track record with the IMB/FDA.
  • A proven identifiable track record of success in a similar environment.
  • Developed leadership skills that lead to results through people.
  • Experience in managing change and seeking continuous improvements.
  • Have an understanding of, or exposure to Operational Excellence principles

 

 

Ref: QA ManagerC
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