Compliance Specialist

Role Purpose:

• A fantastic new opportunity has arisen for a Compliance Specialist to join our client’s busy pharmaceutical site in Co. Carlow.
• The successful candidate will be responsible for supporting the client’s Engineering Department in a GMP and Sterile Environment.
• Ensure that objectives are effectively achieved, consistent with company requirements to ensure compliance, safety and reliable supply to their customers.

Core Duties and Responsibilities:

• Direct and lead deviations, out of tolerance conditions and unexpected results, conducting failure analysis, root cause determination and implementing corrective actions.
• Preparation and analysis of Engineering metrics reports to trend for improved operational efficiencies.
• Format, write, deliver and review necessary documentation in line with the standard approval process, and facilitate others to do so.
• Documents will include SOPs, SWIs, training documents, JSAs, PMs and change controls.
• Accountable for leading investigation analysis, identifying true root cause, identifying gaps and actions to close gaps.
• Collaborate with Engineering colleagues and other departments particularly IPT, Quality, EHS, Technical Engineering in completion of tasks.
• Required to comply with Company 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.
• Work collaboratively to drive a safe and compliant culture on site.
• May be required to perform other duties as assigned.
• Support Audit Readiness activities.

Education & Qualifications Required:

• Diploma or higher preferred, ideally in a related discipline.
• Prior related work experience; ideally in a manufacturing, preferably GMP setting.
• Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
• Report, standards, policy writing skills required.
• Sterile filling processes and equipment experience preferred.
• Proficiency in Microsoft Office and job-related computer applications required.
• Lean Six Sigma Methodology experience desired.
• Effective communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment, and with external customers.
• Understand the specific responsibilities of all Co. Carlow departments as they relate to one’s own department, understanding the business processes one's department supports.
• Customer service orientation.
• Self-motivated & Flexible approach.
• Effective time management and multi-tasking skills.
• Proven organizational skills & Excellent attention to detail.
• Data analysis capabilities.
• Training skills & Ability to start and finish tasks.
• Troubleshooting skills & Goal/results oriented.