Quality Control Chemist

About the Role

A well-established and rapidly growing pharmaceutical manufacturer located in Tipperary, Ireland is seeking a Quality Control Analyst to join their team. Operating from a state-of-the-art facility, the company specializes in developing and producing complex and high-value medicinal products including inhalation therapies and other specialty treatments. This role offers an exceptional chance to contribute to a site advancing towards full commercial operations with ongoing investments in manufacturing and research.

Responsibilities

• Assist in setting up the laboratory and preparing it for operational activities.
• Develop and maintain laboratory protocols, procedures, specifications, and reporting documentation.
• Perform analytical tests and investigations adhering to SOPs, current Good Manufacturing Practices (cGMP), and regulatory standards.
• Carry out peer reviews of laboratory documentation to ensure accuracy and compliance.
• Participate in analytical method verification, validation, and technical transfer tasks.
• Manage laboratory supplies, including procurement and inventory management.
• Support equipment qualification and calibration processes.
• Help prepare for audits and maintain continual readiness for inspections.
• Coordinate with external laboratories and vendors, including auditing engagements as needed.
• Ensure compliance with internal policies and regulatory requirements at all times.
• Maintain a tidy, organized, and compliant laboratory work environment.
• Conduct routine calibrations of analytical balances.
• Work collaboratively with cross-functional teams such as technical, engineering, and operations departments.

Requirements

• 3 to 5 years’ experience working in a GMP-regulated pharmaceutical or biotechnology Quality Control laboratory environment.
• Proficient with analytical instruments such as HPLC, GC, and analytical balances; experienced in method validation, verification, and technical transfers.
• Strong knowledge of cGMP regulations and proven capability to conduct tests in compliance with SOPs and regulatory frameworks.
• Experience in thorough documentation practices, including data review aligned with Good Documentation Practices (GDP).
• Competency in problem-solving, including supporting deviation investigations, CAPA processes, and root cause analyses.
• Previous involvement in audit readiness and participation in regulatory inspections or audits.
• Must hold legal authorization to work in Ireland.