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QA Specialist

  • Job reference: 930070
  • Location: Dublin South, Dublin
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 18/02/2020

Orion Group Life Sciences are looking for a QA Specialist for our Multinational Pharmaceutical client based in the South of Dublin area on an initial 12-month contract with the potential to extend.


Job Purpose

The Specialist QA is a position reporting to the Senior Manager, QA (ESQ). The QA Specialist will be required to understand and grasp a wide range of quality related competencies while providing high complexity tactical support to a dedicated Quality Site Lead across multiple Quality Systems and Processes.

Main Responsibilities of the role

  • Provide tactical information to the networks (i.e., metrics to management, data analysis, trending, periodic monitoring, APR)
  • Support the day to day with regards CMO quality oversight at a dedicated CMO including change notifications, deviation management, validation activities, CAPA oversight and implementation tracking
  • Partner with the dedicated Quality Site Lead to manage urgent requirements to meet the business needs with a keen focus on quality & compliance
  • Support regulatory requests
  • Escalate risks or roadblocks to management
  • Drive timely decision making using company decision making principles
  • Drive continuous improvements and company first mindset
  • Demonstrate ownership for required training on required Quality Systems (Trackwise, LIMS, SAP, Complaints, and others as applicable)
  • Engage &/or participate with ongoing improvement initiatives within the Regional work cell and the wider organisation
  • Create and foster an environment of change and development within the European Regional Group and seek to influence beyond
  • Create and foster key relationships to enable timely completion of activities and responsibilities
  • Own Quality record content
  • Identify opportunities and issues, then determine when escalation is necessary
  • Proposes revisions to SOPs in area of responsibility
  • Identifies key improvement opportunities and highlights to management

Desired Experience and Background of the successful candidate

  • Bachelor's Degree in a Science Field
  • 4+ years of quality and manufacturing experience in biotech or pharmaceutical industry
  • CMO experience, working for CMO or involved with a quality oversight of CMO
  • Familiar with SAP and trackwise
  • Change management experience
  • Change control
  • cGMP Experience
  • Ability to oversee multiple projects simultaneously
  • Able to successfully manage workload to timelines
  • Ability to negotiate a position after taking feedback from multiple sources
  • Demonstrated ability to consistently deliver on-time, and high-quality results
  • Ability to operate in a matrixed or team environment
  • Understanding of the applicable manufacturing/testing processes (i.e. Large molecule, Drug Product)


#pharmaceutical #pharma #multinational #product #QA #qualityassurance #Trackwise #SAP #LIMS #GMP

For more information on this role, call Kate O' Sullivan on +353 (0) 212063412 or email Kate.OSullivan@orioneng.com for a completely confidential chat about this role and other opportunities using the reference number: 930070


Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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