Senior QA Specialist

2021-12-20 17:33:022049-05-05Team Horizon
Job TypeContractor
AreaDublinDublinIreland
SectorQuality
Start Date
AdvertiserAshling Guthrie
Job Ref#2297
Job Views94
Description
If a Senior Quality Assurance Specialist sounds like the job, you'd be perfect for, we'd love to hear from you! We are currently actively seeking candidates to fill this position on a maternity cover contract.  In this role you will be responsible for ensuring that manufacturing, testing, labelling, and storage of Bulk Drug Substances comply with all applicable regulations. This responsibility includes the oversight of the QMS to ensure that quality and compliance requirements are followed in line with business needs.
 
Why you should apply:
  • Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.
  • The role is generously compensated, and attracts a competitive base salary and highly attractive benefits package.
  • Excellent career progression opportunities.
 
What you will bedoing:
  • Provide quality and cGMP input and oversight for all start-up project activities through commercial and multiproduct 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 company internal procedures and GMP principles.
  • Responsible for review and approval of Master electronic Batch Record recipes in accordance with company internal procedures 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 criticality 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
 
 
What you need to apply:
  • 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.
 
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