Senior Fill & Finish expert GMP

ppbagap2 /b is a European engineering and operational consulting group founded in 2005 and specialized in the industry. We work in the Pharma, Biotechnology, Medical Devices, Energy, Infrastructure, Transportation, Chemicals, and Information Technology sectors. /p pbAs a consultant /b, you will have to support our clients in the realization of their projects on site by bringing your expertise and your skills. /p pYou are agile and eager to adapt to different work environments that will fuel your curiosity of seeing what’s behind closed doors of the biggest projects of our client’s portfolio. /p h3Your main responsibilities /h3 ul liDrive continuous improvement of the GMP quality system for Fill Finish, ensuring inspection readiness /li liSupport batch release through rigorous review of batch records and manufacturing documentation /li liReview and approve GMP documents (SOPs, protocols, reports) related to aseptic processes and equipment /li liAct as SME for process validation and equipment qualification (URS, FAT/SAT, IQ/OQ/PQ) /li liLead investigations (deviations, CAPAs, OOS, complaints) using a risk-based approach /li liManage change controls impacting processes and systems /li liEnsure oversight of aseptic operations (media fills, CCS) /li liOversee qualification and lifecycle of Fill Finish equipment (filling lines, isolators, lyophilizers) /li liManage CMO quality oversight and external partner performance /li liContribute to APQR and support audits and inspections as SME /li /ul h3Your profile /h3 ul liMaster’s degree in Pharmacy, Engineering, Biotechnology, or Quality /li li3–8 years of GMP experience in pharma/biotech /li liStrong expertise in Fill Finish (aseptic processing, sterile manufacturing, equipment qualification) /li liGood understanding of USP, DSP, Fill Finish /li liSolid knowledge of cGMP (EU GMP, FDA) /li liExperience in aseptic environments (isolators, cleanrooms, CCS) /li liBackground in validation/qualification activities /li liStrong analytical, communication, and stakeholder management skills /li liComfortable in a cross-functional, international environment /li liFluent in English and German (mandatory) /li /ul pThank you for your interest in this opportunity, please note that only the selected candidates for a first exchange will be contacted. /p /p #J-18808-Ljbffr