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Senior QA Associate 30524

  • Job reference: 934324
  • Location: Dún Laoghaire, Dublin
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 02/03/2021

Orion Group Life Sciences have an exciting opportunity for a Senior QA Associate for our Multinational Biotechnology client based in the South of Dublin area on an initial 12-month contract with the potential to extend.

Job Purpose

The Plant Quality Assurance (PQA) Snr Associate will report to the QA Manager and will be a core member of the site Quality Assurance team. The PQA Snr Associate will serve as Quality point of contact for manufacturing operations. The site is focused on continuous improvement of all work processes and practices, therefore in addition to routine Quality Assurance duties, PQA Snr Associates may be asked to carry out additional work functions to support site continuous improvement activities. This is a 24/7 shift role required to support manufacturing operations. (Primarily dealing with manufacturing activities, trouble shooting issues in production. Quality contact on deviations. Batch record review for manufacturing.
SOPs. filling, setups and work on lines, triage issues relating to manufacturing activities, reviewing complaints)

Main Responsibilities of the role

  • Perform all activities in compliance with safety standards and SOPs.
  • Write, review and approve Standard Operating Procedures in accordance with Policies.
  • Provide Quality support for triage and investigation of all classes of non-conformance (NC) events.
  • Review and approval of Non-conformances and CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable.
  • Participates in customer complaint investigations.
  • Provides training and advice to staff in order for them to perform their desired functions.
  • Observe and provide real-time quality oversight, and support for production unit operations, extending to formulation, vial and Syringe Fill Finish related activities, including observation and provision of direction during media fills and assessment of aseptic interventions.
  • Review/approve production batch records, and associated documentation in preparation for Qualified Person disposition activities.
  • Review and approve cGMP records ensuring compliance with appropriate documentation.
  • Support continuous improvement and Operational Excellence initiatives.
  • Any other tasks/projects assigned as per manager's request.

Desired Experience and Background of the successful candidate

  • Min industry experience 2 years + (Ideal candidate would have at least 3 years experience, QA background who has worked in a sterile manufacturing area)
    Candidates need to be happy to work on shift.
  • Candidate's need to have good examples of trouble-shooting and ability to work alone.

Preferred Qualifications & Experience:

  • Experience working with dynamic cross-functional teams and proven abilities in decision making.
  • Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non Conformance /Deviation investigations.
  • Experience working in aseptic operations, protein formulation, vial and syringe filling.
  • Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues

Basic Qualifications & Experience:

  • University degree. Engineering or Science related discipline preferred.
  • Relevant experience (4 yrs +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.

Shift Pattern

Team is made up of 4 managers, 3 people on each shift (12 hours shifts.) The role is to cover mat leave. Hopeful FTE role after Shifts will start approx 3 weeks from start date for training a shift allowance applies

For more information on this role, call Ian Towler on +353 (0) 212063411 or email for a completely confidential chat about this role and other opportunities using the reference number: 934324

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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