Quality Compliance Specialist

Our client, a leading pharmaceutical manufacturing organisation, is seeking a Compliance Specialist to join their Quality team on an initial 6-month contract, with the potential for extension to 9 months. This is an excellent opportunity for an experienced quality professional to support the development, maintenance, and continuous improvement of the site's Quality Management System (QMS), ensuring compliance with cGMP, regulatory requirements, and internal quality standards.

Key Responsibilities: 

• Support the maintenance and continuous improvement of the site's Quality Management System.
• Ensure compliance with applicable regulatory requirements, including cGMP, HPRA, FDA, and company standards.
• Participate in Quality Risk Management activities, including FMEA and Risk Control Strategies (RCS).
• Support internal and external audit and inspection readiness activities, including preparation, logistics, response generation, and evidence management.
• Initiate, investigate, and complete quality-related events, deviations, and compliance records.
• Provide quality guidance and approval for validation activities across the site.
• Monitor quality performance metrics and contribute to management review reporting.
• Review and implement quality policies and procedures.
• Support the investigation of quality events and drive effective CAPA implementation.
• Coordinate Change Control activities and support change planning.
• Assist with Product Quality Reviews (PQRs) and quality trend analysis.
• Manage technical agreements throughout their lifecycle.
• Support vendor qualification and requalification activities.
• Review and approve quality and validation documentation.
• Assist with customer complaint investigations where required.
• Deliver quality-related training and provide guidance to cross-functional teams.
• Promote a culture of continuous improvement, compliance, and Right First Time principles.
• Ensure compliance with all Environmental, Health & Safety (EHS) policies and procedures.

Experience / Qualification: 

• A third-level qualification in Science, Quality, Pharmacy, Engineering, or a related discipline.
• A minimum of 2 years' experience within a Quality or Compliance role in a regulated pharmaceutical, biotechnology, or medical device environment.
• Strong knowledge of cGMP and regulatory requirements.
• Experience working with Quality Management Systems (QMS).
• Experience supporting investigations, CAPAs, Change Controls, and quality documentation.
• Excellent problem-solving and analytical skills.
• Strong written and verbal communication skills.
• Excellent attention to detail and documentation practices.
• The ability to work independently while collaborating effectively across multidisciplinary teams.
• A proactive approach to quality, compliance, and continuous improvement.

For a confidential conversation about the role please apply for the role or contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose.