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Contact Info
Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

QA Associate - Materials Management


Reference:SCAWJK-638002 Location: Limerick
Limerick City
Qualification:DegreeExperience:2-3 Years
Job Type:PermanentSalary: Not Disclosed

QA Associate

My client are seeking highly motivated, talented Quality Assurance Associate to support their new Biologics Manufacturing Facility. The ideal candidate is an organised and a methodical professional who fosters a positive team environment.

Main Purpose and Objectives of the Position:

  • Provides Quality leadership, direction and governance for materials management.
  • Assures consistent implementation of standards across the quality system.
  • Manages quality-related matters specific to Materials
  • Is responsible for approving appropriate quality-related documents.
  • Performs ongoing monitoring that includes:
  • Monitoring of quality systems,
  • Materials Management area time on floor (TOF) audits, self-inspection program
  • Verification of the effective implementation of key GMP programs and
  • Review of systems that impact Product Quality to ensure that they operate in a state of control.
  • Establishment, maintenance and management of a control system for and training of individuals in the specific Quality System and/or Quality Program assigned.
  • Continue to provide coaching and mentoring to operations personnel and to other QA reps, on the appropriate risk management to provide appropriate and timely solutions to compliance in a business focused fashion.
Key Responsibilities:
  • Develop and implement Quality system for materials management including, SOPS, Quality agreements and Risk assessments
  • Review and approval of change controls, deviations, failure investigations, product quality complaints associated with the area(s) of responsibility
  • Reports & escalates critical quality issues to the appropriate level of quality management for final resolution.
  • Review and approval of GMP documents associated with qualification and validation including but not limited to change controls, IQ/OQ/PQ & validation documents for equipment, computer systems, log books, processes and periodic product quality evaluations as appropriate to area of responsibility.
  • Review and approval of other key GMP documents such as GMP standard operating procedures, sample protocols, splitting documents as appropriate to area of responsibility
  • Understand the GQS/CQP and how they apply to process team – Monitoring and Maintenance of all aspects of GMP compliance
  • Participate in quality risk management activities such as FMEA’s. Assess the impact on product quality of issues associated with materials and consumables.
  • Audit & participation in the Site Self-Inspection program of the area(s) of responsibility for compliance with the Product Quality System policies, procedures and guidelines.
  • Monitoring of GMP compliance, GMP programs & systems by ensuring a regular presence in area of responsibility
  • Communication and education of personnel in GMP requirements and regulations related to the area(s) of responsibility
  • Contribution to the GMP Plan for Materials Management Initiatives
  • Maintenance of all aspects of GMP compliance for the area(s) of responsibility
  • Establishment, maintenance & management of a control system for the specific Quality System(s)/Program
  • Assess the impact on product quality of quality deviations associated with the process team.
  • Assure robust Root cause Analysis and effectiveness of investigations.
  • Responsible for Batch Disposition (re-identifications / re-evaluations), including approval of raw materials and packaging components (manual disposition when required) used in the manufacture of Drug substance products
  • Assurance that the Quality System(s)/Program remains in a validated state and within regulatory commitments.
  • Interpretation and application of emerging regulatory and GMP guidelines to the specific Quality System(s)/Program.
  • Support slow moving inventory and product discontinuation initiatives
  • Facilitate compliance with process team commitments such as deviation cycle time, Backlog etc
  • Liaison between process team and other quality areas
  • Benchmarking of current and emerging Materials Management initiatives.
  • Develop personal knowledge about the manufacturing process of the product(s) including but not limited to facilities, procedures, people expertise and quality systems.
  • Ensure the required relevant knowledge and experience/training necessary to fulfil duties is acquired.
  • Re-identification of damaged material if undamaged portion of a lot is to be used.
  • Responsible for providing quality support in relation to packaging and supply chain cover
Basic Qualifications:
  • BSc, Msc, or PhD in Chem, Eng or Science related discipline with appropriate experience
  • Minimum of 3 years’ experience in GMP operations
  • Materials Management Experience

For further information, contact Sinéad on [email protected]/ +353 87 9500821