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QA Manager – Pharmaceutical


  • to €75K
  • North County Dublin
  • Permanent

Our Client, based in North County Dublin provides contract QP services to enable clients to import and QP Release human medicinal products into Europe in a compliant manner with no significant investment in licence application, maintenance activities or office/personnel costs. They currently have a vacancy for a QA Manager to join their expanding team.

Salary:  to €75K

Benefits:  Bonus, Pension, Health Cover, Free Parking.

Purpose of the Role: 

To provide key support to the HOQ in all matters relating to the provision of technical delivery of client projects. The person will take on full responsibility for managing QA activities relating to delivering of client projects and maintenance of the Quality System and to ensure that the operational business is in compliance with GMP.

Principal Responsibilities:

  • Management of quality systems including but not limited to:
  • Deviations
  • CAPA
  • Change Control
  • Audits
  • Customer Complaint

Be responsible for review and approval including but not limited to the following documents:

  • Failure investigations
  • Change control documents
  • Corrective/preventative action documents
  • Standard operating procedures
  • To maintain electronic databases; for example, Change Control and Deviation Management.
  • Manage preparation of batch doc files and issues arising to facilitate batch release in a timely manner to meet client requirements.
  • Development and approval of procedures, policies and other instructional documents
    relating to quality systems to ensure compliance with company policy and local and international regulatory requirements.
  • To provide monitoring and trending metrics associated with company quality systems.
  • Actively participate in continuous improvement initiatives.
  • Participate in regulatory and customer audits as required.
  • Collaborate with contract parties to resolve issues and maintain compliance.
  • Identify gaps in systems and develop feasible plans for correction.
  • Manage and participate in internal audit schedules as per the agreed plan.
  • Manage and drive supplier qualification activities ensuring Approved Supplier Lists are maintained.
  • Co-ordinate and manage Product Quality Reviews and proactively identify any areas where compliance gaps or significant negative trends may exist.

The Candidate: 

  • 3rd Level Qualification in Science or Quality Management
  • Minimum of 10 years’ experience in GMP, preferably in sterile and biotech drug products encompassing Quality Management or Compliance role.
  • High level Computer Literacy and competency – Microsoft Office, Microsoft Project.
  • QP Status / QP Eligibility (Preferably)
  • Vendor Auditing Experience
  • Knowledge, Skills & Behaviours Knowledge
  • In-depth understanding of regulatory requirements applicable to the Pharmaceutical Industry, and knowledge of the sources of regulatory information (medical devices and cosmetics industries also considered).
  • In-depth understanding of the purpose, objectives and scope of Quality Systems

If this QA Manager vacancy sounds like you, call Orla for details on 01 8456312.

Speak to the experts with the direct LINK to all the best QA Vacancies in Ireland.

www.linkpersonnel.ie

01 8456312

 


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