AD Analyst
- Cork
- Permanent
- Full-time
- Develop and optimize new or established analytical methods.
- Validate analytical methods, including issuing or upgrading validation reports, ensuring strict compliance with regulatory expectations.
- Manage change controls for analytical and instrument changes as required.
- Participate in technology transfer meetings and coordinate the procurement and installation of new equipment.
- Perform bench evaluations of key analytical methods, applying Quality by Design (QbD) principles.
- Provide technical support to Quality Labs during validation campaigns.
- Document training and proficiency testing and develop training materials.
- Carry out analysis and data review of AD sample testing, including non-routine and supplier assessment samples.
- Prepare reports detailing investigations and conclusions of quality issues.
- Support internal and external inspections, ensuring the AD laboratory is always ready.
- Troubleshoot laboratory equipment and manage service engineers as necessary.
- Engage in cross-functional teams to ensure timely completion of project achievements.
- Bachelor's degree in Chemistry, Biochemistry, or a related field; advanced degree preferred.
- Minimum of 3 years of experience in analytical development and validation.
- Strong understanding of GMP compliance and regulatory requirements.
- Proven ability to lead technical projects and work effectively in cross-functional teams.
- Outstanding communication, facilitation, and presentation skills.
- Positive attitude, enthusiasm, and a can-do approach to problem-solving.
- Demonstrated leadership, influencing, and negotiating skills.