QA Specialist – Compliance and Quality Systems

Job title:

QA Specialist – Compliance and Quality Systems

Company:

Asset Recruitment

Job description

ref. 01246QA Specialist – Compliance and Quality SystemsExciting opportunity for a QA Specialist to join our client, a leading Pharmaceutical company located in Dunboyne, County Meath.Role
This role will primarily provide support for SAP Quality Master Data build, Master Data approvals hypercare, sustainment, and ongoing updates in addition to providing support interface of SAP with IPI Product structure and MES BOMs and recipes, among other activities relevant to the position.You will work closely with the Operations, Engineering, Validation, Supply Chain and AR&D Functions to ensure compliance to Global and Regulatory Quality Management System requirements as they pertain to the company’s Quality Manual, Change Control, Deviation Management, Supplier Quality Management, Quality Risk Management, Audit Management and associated electronic systems.Responsibilities

• Lead SAP master data build and data approval activities including hypercare, sustainment materials build, BOMs and Recipes.
• Participate daily on cross-functional teams collaboratively and actively to address compliance issues and achieve project milestones.
• Support implementation and training for site Quality Systems and ensures activities align with the current Quality Manual Requirements
• Create and maintain assigned SOPs.
• Support completion of Quality Systems activities e.g. related to Documentation Management, Auditing, Deviation Management, Change Control, Supplier Management and Quality Risk Management, per schedule
• Provide QA review and approval of Change Controls, Deviations/CAPAs, SOPS and related documentation for compliance to GMP and site requirements at the start-up facility.
• Support creation, maintenance and continuous improvement of Quality Management Systems (QMS) and associated documentation.
• Support site QA Operations and QA Validation colleagues, as required.
• Work collaboratively to guarantee strong relationships with management and colleagues and to drive a safe and compliant culture.
• Ensure the escalation of compliance risks to management in a timely manner.
• Support gathering of site metrics.
• Additional activities as assigned by the manager/supervisor

Requirements

• 2-3 years’ experience in an FDA / EMA regulated environment, ideally in Quality Assurance, Quality Control or Technical Operations within the Biological and/or pharmaceutical industry.
• Experience in QMS development and maintenance.
• Bachelor’s Degree or higher, in a Life Science discipline.
• Proven experience in QRM, SQM, Deviations and Change Control, participating in investigations and problem solving.
• Previous experience in quality management systems such as Veeva, SAP, Delta-V, TrackWise, PAS-X etc. or similar.
• Strong attention to detail and precision in preparing and reviewing GMP documentation.
• Strong written and verbal communication skills.
• Knowledge of major Health Authority Guidelines and Regulations related to Biologics and/or Pharmaceuticals.
• Ability to work as part of a team and on own initiative in a constructive manner.

Expected salary

Location

Dunboyne, Co Meath

Job date

Sun, 22 Dec 2024 05:34:18 GMT

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