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Job ID: JOB-12744

Quality Systems Engineer

We are looking to speak with experienced Quality Engineers about this great new job opportunity in Cork with one of our leading clients This company stands out for their culture, exceptional career development pathways and unrivalled rewards and recognition packages.

Apply to us to find out more about this great job opportunity in Quality in Cork and we can talk though if it’s the right job for you. 

Key Responsibilities

• Responsible for maintenance of PQS Global Policies and Procedures (e.g., working with SMEs to ensure that reviews are completed and that where applicable harmonization is maintained between the PQS and the main BSC QMS).
• Support of the Legislation Impact Assessment Team (LIAT) in the assessment of Regulatory and GMP  Rules and Guideline changes
• Management of the PQS helpdesk ensuring it is maintained and functions effectively to support stakeholders.
• Control and Maintenance of; how to use’ Master control system procedures and
• Lead the Master control training provision to Divisional PQS users when required.
• Support for maintenance of job role and training curricula within the system (e.g., assisting with updates and ensuring that scheduled reviews are completed).
• Responsible for supporting configuration and documentation of out of the box modules within the iQMS including review of qualification activities required for quarterly updates.
• Assisting with migration of data into and out of the Master control system.
• Maintaining and managing changes to the system User Requirement Specification and Trace Matrix for recording testing performed against each requirement for the iQMS.
• Responsible for the resolution of any quality system issue with the iQMS encountered during routine use (e.g., minor issue resolution and communication with Master control support to resolve any issues encountered).
• Responsible that defect fixes implemented by Master control are demonstrated to be effective.
• Maintain a strong technical understanding of Quality System regulations, Validation and Data Integrity.
• Good Knowledge and understanding of Pharmaceutical and medical device regulation and Guidelines (QSIT, ISO 13485:2016, ICH Q9, ICH Q10 EudraLex Volume 4 Part 1, GAMP 5)
• Ensure that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with values.
• Carry out other reasonable tasks as required by line manager

Key Requirements

• 2-5 years’ experience in Manufacturing or Quality with a Level 8 qualification in Engineering or related technical/Quality discipline.
• Excellent written and verbal communication skills
• Demonstrated ability to work with cross functional organizations in a dynamic manufacturing environment to solve problems
• Strong command of MS Office – Word, Excel, PowerPoint.
• Ability to rapidly learn and use new applications

Preferred:

• Previous experience in a Quality, or Manufacturing background, particularly in relation to pharmaceutical quality systems
• Experience in the pharmaceutical industry and GMP manufacturing
• Working knowledge and understanding of FDA, HPRA, and the pharmaceutical industry quality requirements and associated with manufacturing controls.
• Experience in problem solving and process improvement methodologies
• Process Validation, Risk Management, CAPA experience.

For further information on this role in please contact Mark Wilson on 0860449473 or email talent@hero.ie

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

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

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.

Mark Wilson

JOB-12744

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