QA Associate – Materials Management

Job title:

QA Associate – Materials Management

Company

Life Science Recruitment

Job description

QA AssociateMy 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 / +353 87 9500821

Expected salary

Location

Limerick

Job date

Fri, 29 Mar 2024 08:23:39 GMT

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