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QA Specialist - Quality Control, Dublin



Dublin, Ireland 

Job Category:

Biotech/Pharma, Science

EU work permit required:


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Job Description:

Team Horizon is seeking a QA Specialist – Quality Control who will be responsible, with management support, for providing oversight of quality activities associated with Quality Control. The incumbent will be responsible for quality oversight of the Quality Control Department. This responsibility includes the oversight with relation to QC to ensure that quality and compliance requirements are followed in line with business needs.

Why you should apply:

  • This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
  • There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
  • Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.

What you will be doing:

  • Responsible for Quality oversight, with management support of quality control.
  • Provide Quality support to QC department to include method transfer or validation/verification activities.
  • LIR review and approval.
  • Provide oversight to continuous quality system improvements and support implementation of improvements in compliance, Calibration, Preventive Maintenance, Deviation Management and the Change Control Programs.
  • Perform review of change controls deviations and CAPA’s.
  • Provide QA and compliance support to projects impacting on Quality Control activities.
  • Provide support and expertise for inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, to monitor progress of follow up actions.
  • Responsible for quality review and approval of Cert of Analysis in accordance with Company’s internal procedures and GMP principles.
  • Review and approval of Company standard operating procedures and controlled documents.
  • Define and follow-up standard quality KPI and to review quality indicators with recommendation for actions for improvement in relation to Quality Control Operations. Identify training needs and organize training interventions to meet quality standards
  • Coordinate and support on-site audits conducted by external providers
  • Evaluate audit findings and implement appropriate corrective actions
  • Monitor risk management activities
  • Assure ongoing compliance with quality and industry regulatory requirements
  • Draft quality assurance policies and procedures
  • Interpret and implement quality assurance standards and procedures
  • Evaluate adequacy of quality assurance standards
  • Devise sampling procedures and directions for recording and reporting quality data
  • Review the implementation and efficiency of quality and inspection system

What you need to apply:

  • Academic degree in natural or applied sciences (Pharmacy, chemistry or analytical sciences or equivalent)
  • Minimum 5 years in international pharmaceutical and/or biotech industry with increased level of responsibility
  • Minimum 3 years of experience in QA for QC
  • Sound awareness and understanding of pharmaceutical business, especially with regards to quality and regulatory requirements.
  • Demonstrated success records in auditing and improvement processes.
  • Ability to operate efficiently in a complex matrix organization and international environment.
  • Management skills for management of a team of experts.
  • Strong mature leadership and interpersonal influencing skills.
  • Ability to represent the company and to negotiate at different levels contacts both internally and externally.
  • Strong verbal and written communication skills with well-structured communication and presentation ability to various audience levels.
  • English fluency written and spoken (the Company language).
  • Efficient in SAP, firstdoc. and Track wise.
Company Info
Team Horizon
1 Cedar Crescent, Cedar Park, Westport, Co. Mayo
Westport, Ireland
Phone: +353 98 50600
Web Site: http://www.teamhorizon.ie
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