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QA Specialist

  1. NI & Ireland
  1. Contract
Competitive
24969/ZM
  1. Compliance / Quality Assurance
Date Posted19 Jun 2020
QA Specialist - Contract - Dublin

An exciting new opportunity for a QA Specialist to join a world Leading bio tech organisation who are at a peak phase in establishing an innovative and industry leading manufacturing facility in Dublin Ireland.

DUE TO TRAVEL RESTRICTIONS CAUSED BY THE CORONAVIRUS WE CAN ONLY ACCEPT APPLICATIONS FROM THOSE RESIDING IN IRELAND AT THIS TIME

Principal Responsibilities
  • Provide quality and cGMP input and oversight for all start-up project activities through commercial readiness for the BDS facility
  • Review and approval technical support documentation. (Examples include cleaning, process, method validation).
  • Review and approval of functional area documentation (SOPs, Work Instructions, technical reports and protocols)
  • Participate in quality risk assessments and provide quality oversight to ensure quality risk assessments are effectively maintained/ controlled.
  • 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 review and approval of Master Batch Records in accordance with GMP principles.
  • Responsible for review and approval of Master electronic Batch Record recipes in accordance with and GMP principles
  • Provide oversight of quality management system activities including Preventive Maintenance, Deviation Management and the Change Control Programs
  • Provide quality oversight of calibration and preventative maintenance critically assessments as required.
  • Author, review and approve Quality Related Procedures as required
  • Support the Vendor Management Program.
  • Support the Raw Material Qualification Program.
  • Develop¬† and report quality metrics
Qualifications
  • Minimum 5 years in international pharmaceutical and/or biotech industry with increased level of responsibility
  • 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
  • Strong mature leadership and interpersonal influencing skills
  • 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, EMDS, MES and Trackwise.

Education
  • Academic degree in natural or applied sciences (Pharmacy, biology, biotechnology, engineering)
If this seems like the role for you, apply today!




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