Job Detail

Location Galway
Salary Negotiable
Posted
Role Type Permanent
Contact Clara Burke
email science@hero.ie

QP – Qualified Person

Job ID: JOB-11519
My client a leading pharmaceutical manufacturer of both medical and pharma products is recruiting for a QP on a permanent basis at their Galway site.

The role is to assist in the process of maintaining compliance to Product Licences / Marketing authorisations and batch certification accordingly.

In this role you will report to the Senior QA Compliance Manager/QP

Key Responsibilities

  • Responsibility for batch release as per EU guidelines by ensuring the requirements have been met
  • The batch and its manufacture comply with the provisions of the marketing authorisation (including the requirements for importation where relevant);
  • Manufacture has been carried out in accordance with GMP (in the case of an imported batch that it has been manufactured to standards equivalent to EC GMP);
  • The principal manufacturing and testing processes have been validated (account has been taken of the production conditions by review of the relevant documentation);
  • Any deviations or planned changes have been duly Any changes requiring variation to the marketing authorisation have been notified and authorised by the relevant authority.
  • All necessary production and Quality Control documentation has been completed and endorsed by the appropriate staff;
  • All audits have been carried out as required by the QA system;
  • Conduct Routine Quality Audits of the facility to ensure compliance with current EU GMP, be proactive in resolving issues
  • Set up and maintain the Internal Audit schedule and ensure its completion
  • Conduct External audits, compile External Audit reports and manage associated
  • Management and assistance with the site change control
  • Provide technical support for New Product Introductions and existing Products, ensuring compliance with the registered dossier
  • Provision / Updating of existing Quality Manual Procedures in order to ensure compliance with EU GMP
  • Perform 3rd party management activities, including audit of suppliers and contract resource organisations, utilizing third party assessment
  • Review and approve process and cleaning validation protocols and reports

Key Requirements

  • As a Qualified Person, is personally accountable to conform to the legal regulatory requirements as stated – Directives 2001/20/EC and Article 51 of Directive 2001/83/EC.
  • Minimum 2 years’ experience in a similar role
  • Experience of implementing and maturing a quality management system
  • Proven experience in change and project management
  • Ability to develop and lead continuous improvement initiatives
  • Experience of direct line management
  • Organizational skills, personal efficiency, time management skills and the ability to prioritize competing demands are key communication
  • Ability to lead a team and to build relationships and collaborate
  • Practical, action-orientated approach to managing priorities

For further information on this role please contact Clara Burke on 086 816 8273/ science@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

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Clara Burke

JOB-11519

QP – Qualified Person

Clara Burke

Role Type Permanent
Contact Clara Burke
email science@hero.ie
mobile +353 86 816 82 73
linkedIn profile click here

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