Job Purpose
Perform and document testing of raw materials, intermediates, and drug substances in compliance with analytical standards and approved protocols.
Provide analytical support for quality investigations, technology transfers, method development, stability programs, and training of laboratory personnel.
Principal Accountabilities
- Perform testing of raw materials, intermediates, drug substances, and drug products in line with approved methods and specifications.
- Ensure compliance with cGMP, data integrity, safety, environmental, and company requirements.
- Accurately document testing activities and maintain laboratory records in electronic systems.
- Support and lead analytical investigations, including OOS and quality notification activities.
- Review and verify analytical data and batch documentation prior to product release.
- Provide analytical support for process changes, technology transfers, product demonstrations, and non-routine testing.
- Identify, troubleshoot, and resolve analytical and laboratory-related issues.
- Lead or contribute to continuous improvement, change management, and site initiatives.
- Serve as a technical resource and subject matter expert for analytical testing and laboratory systems.
- Train, mentor, and support the development of laboratory analysts and apprentices.
Core Competencies
Technical
Business
Leadership
Technical
- Knowledge of GMP, quality systems, laboratory safety, and site procedures related to analytical testing and product release.
- Proficiency in analytical techniques, instrumentation, maintenance, and troubleshooting.
- Strong understanding of data integrity and ALCOA principles.
Business
- Perform analytical testing with accuracy, precision, and compliance.
- Maintain complete and accurate laboratory documentation and records.
- Communicate technical information clearly and effectively.
- Support projects, audits, investigations, and cross-functional collaboration.
- Deliver training and knowledge transfer to laboratory personnel.
Leadership
- Demonstrated expertise in analytical chemistry and laboratory operations.
- Strong technical, problem-solving, communication, and interpersonal skills.
- Ability to lead initiatives, influence outcomes, and work independently.
Educational Requirements
- BSc in Chemistry or a related scientific discipline.
Rate:
Not specified
Location:
Tipperary
IR35 Status:
Outside
Remote Status:
Not specified
Industry:
Science
Seniority Level:
Entry Level