Job description

Summary:
A Quality Specialist is required for a biopharmaceutical company in Carlow. The incumbent will work They will work within a small team that will be mainly responsible for compliance aspects within the Engineering CoE team. This will include but not limited to the completion of investigations, generation and management of change controls and supporting the IFM Compliance and EHS Engineer as required.

Responsibilities:

• Support engineering activities through documentation generation, equipment and process investigations associated with GMP activities and completion of quality notifications.
• Be a document system expert; this will include document review, approval and document system work flow expedition. Format, write, deliver and review necessary documentation in line with the standard approval process, and facilitate others to do so. Documents will include SOP’s, SWI’s, training documents, and change controls.
• Raise CAPA's and conduct investigations. Raise and investigate quality notifications using standard tools and methods, to resolve system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.; implement subsequent corrective action through the change management system.
• Required to comply with Merck Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
• Support and lead Internal Quality audits of Engineering Dept.

Assist in the management and/or assignment of Engineering training if required

• Work collaboratively to drive a safe and compliant culture in Carlow.
• May be required to perform other duties as assigned.

Qualifications & Experience:

• Degree qualification or equivalent Min Level 7 (Science, Engineering, Technical).
• Work experience in pharma (ideally working in a clean utilities and/ or compliance environment) and familiarity with a highly regulated environment.
• Knowledge of and experience in applying Six Sigma and Lean methodologies.
• Experience in Compliance systems such as IPI, SAP etc a distinct advantage.
• Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
• Report, standards, policy writing skills required.
• Proficiency in Microsoft Office and job related computer applications required
• Lean Six Sigma Methodology experience desired.
• Experience working within an Engineering environment in a regulated industry a distinct advantage.

Job Type: Fixed term
Contract length: 11 months

Salary: From €30,000.00 per year

Schedule:

• Day shift

Ability to commute/relocate:

• Carlow, County Carlow: reliably commute or plan to relocate before starting work (required)

Work authorisation:

• Ireland (required)

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