Assure that all raw materials, in-process samples, intermediates or final products are appropriately analysed and authorised. In the event of non-conformance to acceptable quality and/or safety standards, ensure appropriate investigations are undertaken and documented, using Root Cause Analysis techniques where appropriate. Ensure all associated countermeasures are complete.
Review and approve analytical procedures, investigations, and deviations.
Own and review change controls pertaining to analytical methods, procedures and equipment.
Execute and/or provide technical oversight on the writing of analytical methods, method validations/verifications/transfers and procedures. Ensure all validations/verifications/transfers are in line with current expectations and standards.
Provide guidance and training to other team members on updates to the cGMPs, which pertain to testing
Keep current with cGMPs.
Investigate and report on customer complaints and recommend countermeasures.
Support the writing of Annual Product Reviews (APRs) on Active Pharmaceutical Ingredients.
Prepare/Review the analytical sections of other regulatory documents e.g. RCDs, Monographs, Dossiers and ensure full compliance to these requirements.
Provide technical support to Lab analysts and other technical staff.
Source, purchase, install and qualify analytical equipment in accordance with local procedure.
Assist in ensuring that lab equipment is satisfactorily qualified and maintained.
Assist in developing, implementing and maintaining the Lab Quality System.
Assist in ensuring that analytical operations are undertaken safely.
Assist in developing Site Quality Systems.
Support and participate in self-inspection or other audits with particular reference to the analytical aspects of cGMPs as defined by the Health Authorities, Food and Drug Administration, etc.
Ensure that appropriate analytical technology is used for new and existing, processes and equipment to the site. Where required develop and validate the appropriate technology and facilitate transfer of analytical methods to & from other manufacturing sites & development organisation, where required.
Work with production teams to improve the state of validation and drive variability reduction.
Assist in education of teams in the role and capability of the Quality Control Laboratory Team.
Benchmark best practices for analytical technology and operations and implement appropriate improvements.
Provide input to operation of associated team. Participate where required in the development and implementation of business plans.
Where required, interact with contract suppliers to oversee the delivery of analytical testing services.
Internal Number: 50934
About Eli Lilly & Company
Company Overview At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees worldwide work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.