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QA Specialist 30364

  • Job reference: 933507
  • Location: Dún Laoghaire, Dublin
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 14/01/2021

Job Purpose

QA Specialists may be assigned specific oversight and responsibilities for key quality systems or processes and may also serve as a primary quality partner/point of contact for functional areas within ADL, including Supply Chain, Information Systems, Manufacturing, Process Development, Validation, Engineering and Quality Control. QA Specialists may be cross trained and/or assigned additional project specific duties, including continuous improvement/operational excellence initiatives.

Main Responsibilities of the role

General QA Specialist Responsibilities:

  • Perform all activities in compliance with the client's safety standards and SOPs
  • 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 the client's Policies.
  • Participate in site activities associated with QMS programs (e.g., Validation, Complaints, and 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, 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.

Incoming QA & Disposition Function (may perform some or all of these duties)

  • Provide overall quality direction and oversight for key functional areas including the Warehouse, Supply Chain, Sampling activities, and the inspection and testing of incoming materials.
  • Act as Quality point of contact and decision maker for investigations, change controls, and other associated quality related 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.
  • Co-ordinates and approves the preparation of reports for Product Quality Reviews including batch listing and deviation trend reports to ensure that trends are acted upon and to demonstrate that products consistently meet desired critical quality attributes.
  • In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role

Desired Experience and Background of the successful candidate

Basic Qualifications
* University degree. Engineering or Science related discipline preferred.
* Relevant experience (8yrs +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.
Preferred Qualifications
* Experience working with dynamic cross-functional teams and proven abilities in decision making
* Strong organizational skills, including ability to follow assignments through to completion
* 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.

For more information on this role, call Ian Towler on +353 (0) 212063411 or email ian.towler@orioneng.com for a completely confidential chat about this role and other opportunities using the reference number: 933507


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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