IntroductionYou have strong people management and communication skills? You are dynamic and stress resistant? This job is for you!
OrganizationOur client is an expert contract manufacturing partner helping leading pharmaceutical and biotechnology companies to success in making lives of their patient more healthier. To reinforce his QC Department, he is currently looking for a (m/f) QC Manager !
FunctionYou will be working as part of the Quality Department ensuring products are manufactured, stored and packaged in accordance with cGMP. You will directly report to the Head of Quality. Your main task consist to manage a team of approximately 10 QC Analyst and to ensure timely, accurate completion of all QC activities.
– Ensuring follow-up of day-to-day activities, supervising implementation and progress of the QC activities.
– Managing SOPs, change controls, deviations, OOS and CAPA.
– Ensuring smooth running of the lab: on-time & GMP-compliant analyses; housekeeping of the lab.
– Develop and/or review departmental documentation including test methods, SOP’s, protocols and reports ensuring compliance with cGMP and applicable regulatory guidelines.
– Validation of analytical methods : need to be able to set up and write validation protocol, to analyze the validation results and provide conclusion, to release the validation report.
– Implementing and validating the new analytical methods after development phase.
– Stability studies management and results interpretation.
– QC release of raw materials, intermediates products and finish product.
– Technical support during customer audit and regulatory inspections (FDA, AFMPS, other).
– Coordinate laboratory equipment acquisition, qualification, calibration and preventative maintenance.
– Leading QC optimization processes and Operational Excellence QC project.
Requirements– University degree in a scientific discipline with analytical background (Chemistry is an asset)
– 8 years with 5 years in a similar role in the pharmaceutical industry
– Strong laboratory skills and good knowledge of analytical chemistry
– Very good knowledge of cGMP in a regulated environment (US and Eur)
– Experience with guidelines, standards (ICH, Pharmacopea, 21CFR part 11)
– People management experience
– Strong problems solving skills, issue resolution and root cause analysis
– Customer oriented, team player, focused on improvement
– Able to work independently in a fast paced multitasking environment.
– Language : French, English