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Job ID: JOB-13243

Senior Quality Compliance Specialist

Purpose

This role participates in maintaining site compliance of operations inclusive of but not limited to Manufacturing, Quality Systems, Quality Control, Quality Assurance, Facilities Maintenance, Engineering, Materials Handling, and QA Validation in accordance with mandated regulatory requirements and site expectations. 

Key Responsibilities

• Responsible for ensuring compliance with all aspects of Quality for the site inclusive of manufacturing, quality systems, quality control, validation, facilities, and materials management.
• Maintains regulatory compliance in accordance with current Good Manufacturing Practices (cGMP).
• Collaborates with cross functional teams to resolve issues, complete investigations and maintain compliance.
• Responsible for QA review and approval of the following types of documents:

• Failure investigations  
• Corrective and preventative actions (CAPA)
• Standard operating procedures (SOP’s)
• GxP documents
• Change control documents

• Lead & support investigation root cause and resolution ensuring appropriate CAPA actions implemented to prevent recurrence where relevant.
• Reviews procedures, policies and other instructional documents relating to quality systems to ensure compliance with company policy and local and international regulatory requirements.
• Provision of monitoring and trending metrics associated with site quality systems.
• Actively participate in continuous improvement ideas, initiation, and implementation.      
• Participation in internal, regulatory and customer audits.
• May train personnel on quality system processes.
• May supervise team members.
• Perform additional duties as requested. 

Knowledge and Experience

• To be considered for this position you must hold a BS/BA in scientific discipline or related field with 5+ years or MS 4+ years of relevant work experience in pharmaceutical or related industry.  Relevant experience may be substituted for education requirement.
• Experience with determining root cause and working knowledge of root cause analysis tools required.

For further information on this role in Limerick please contact Aisling Kidney on 0872197421 or careers@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

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Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given.  You have supplied us with your personal data in the process of applying for a position.  Our client company may have personnel outside of the EEA who will review you data.  We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

Aisling Kidney

JOB-13243

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