Job DescriptionThis position is responsible for carrying out tasks and projects related to Equipment, lab utilities and testing procedures as required by GMP.You will Partner with other Departments to ensure that all QC testing activities are completed in an efficient manner.Strive to become competent in lab methods and procedures.Train other QC analysts in the laboratory when required.Perform analytical testing in relation to method validation and technical transfer activities to ensure all methods meet ICH, USP and EP guidelines.Work across validation, operation, maintenance, calibration and troubleshooting of equipment and its associated software.Write, execute, report on and review IQ/OQ and PQ protocols to detail that all relevant equipment is qualified for cGMP use.Perform routine and non-routine analytical testing activities.Review and approve laboratory test results.Ensure that testing and results approval are completed within agreed turnaround times.Write and review laboratory TMs, SOPs and WIs as directed by company policy.Strive to ensure QC activities are carried out in compliance with product license commitments, cGMP and company quality standards.You will be a valued member of the QC group and provide assistance with other group activities as required and communicates relevant issues to the QC Manager.Deputizes for the QC Team Leader as appropriate.Maintains and develops knowledge of analytical technology as well as cGMP standards.Key Individual Contributor CompetenciesBuilds strong productive relationships.Demonstrates commitment to work with teams and individualsAsserts personal ideas and opinions using persuasion to influence othersSeeks opportunities to grow and develop professionallyUses standard methodologies to improve business operationsHolds self-accountable for compliant and precise executionTakes personal responsibility for decisions that successfully build customer valueEffectively handles and adapts to changeDemonstrates the courage to standalone opinions that differ from othersListens effectively and remains open to other's ideas.Works effectively with people that have diverse styles, talents and ideasMaintains the highest standards of ethical behaviorTreats people with dignity and respectRequirements A third level qualification of a scientific/technical discipline.Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.PackageSalary negotiable
