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Senior QA Professional - Bio-pharmaceutical/Pharmaceutical

  • Job reference: ORNDW332
  • Location: Dublin South, Dublin
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 16/04/2019

Orion Life Sciences is seeking a Senior Quality Assurance Professional (QA Technical Support & Disposition) for a 3-year contract in Dublin.

The Role:

  • Provide Quality direction and input at Change Control and NC Review Boards and assume oversight of change control and NC/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely.
  • Write, review and approve Standard Operating Procedures in accordance with client policies.
  • Participate in site activities associated with QMS programs (e.g., Validation, Complaints, Change Control) and provide active input into shaping the future direction of these systems.
  • Review and approval of NCs and associated CAPAs for closure ensuring compliance with appropriate documentation
  • Participates in customer complaint investigations.
  • Provides training and advice to staff in order for them to perform their desired functions.
  • Provide overall quality direction and oversight for key functional areas, Process Development, Validation, Quality Control, Supply Chain, Engineering, Information Systems
  • Act as Quality point of contact and decision maker during Technology Transfer and Process Validation activities
  • Site Program Owners for site disposition activities, Quality Agreements, Site Master File, Market Action activities and for the provision of subject matter expertise for related programs including, Complaints, Stability and Product Quality Review.
  • Review and approve validation lifecycle documents, including Master-plans, protocols, reports etc.
  • Co-ordinates and approves the preparation of reports for Product Quality Reviews including batch listing and deviation trend reports
  • Quality SME reviewers/approvers for regulatory submissions

Preferred Knowledge:

  • Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non Conformance /Deviation investigations
  • Detailed Knowledge of applicable Regulatory requirements. Experience with Regulatory inspections.
  • Experience working in aseptic operations, protein formulation, vial and syringe filling.

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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