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Quality Assurance Analyst - Longford

  • Sector: Science & Pharma
  • Contact Email: aideen.cummins@collinsmcnicholas.ie
  • Job Ref: 19049

Our client, a healthcare company based in Longford require a Quality Assurance Analyst to join their team.

The QA Analyst will form part of an internal continuous improvement project who provide quality and compliance support to the project team this role will also encompass batch releasing

Key responsibilities & duties

  • Evaluating current systems and procedures and providing recommendations around improvements at all times ensuring product quality and safety
  • To engage strong interdepartmental and cross-functional/organizational relationships to drive Quality Management Systems improvements
  • Influence and upgrade site compliance to Quality policy, standard operating procedures and guidelines
  • Access compliance to internal and external regulations 
  • Access quality metrics such as CAPA, training metrics completion and complaint resolution metrics
  • Inform appropriate internal departments on audit results and work with the necessary staff to achieve GMP compliance
  • Provide QA support during regulatory authority inspections
  • To manage, provide support to self-inspection for all departments involve in GMP activities.
  • Develop and maintain GMP standard operating procedures in accordance with regulatory and company requirements
  • Manage day to day project related activities
  • Ensure that the manufacturing authorization requirements for the medicinal products have been met for the batches concerned
  • Ensure that GMP/GLP and GDP is adhered to at all times
  • Approve or reject as appropriate starting materials, packaging materials and intermediate bulk and finished products
  • Ensure all necessary testing is carried out and the associated records evaluated
  • Ensure all records are retained adequately
  • Ensure that the production records are evaluated and signed by the authorized person
  • Ensure all quality checks are completed 
  • Participate in the investigation of deviations and Capas
  • Participate and lead as appropriate in customer complaints and product recalls

Education & Experience

  • Level 8 Degree in a Science discipline
  • Minimum 5 years experience ideally with a GMP or microbiology bias 
  • Computer literacy – Excel and Word
  • Quality assurance and quality systems
  • Validation and commissioning
  • Microbiology and aseptic processing

For a confidential discussion and more information on the role please contact Aideen Cummins.

aideen.cummins@collinsmcnicholas.ie

071-9140252