Aseptic Compliance Manager

Our Work MattersAt Kindeva we make products that save lives ensuring better health and well-being for patients around the Aseptic Compliance Manager is a key member of the Quality Assurance Team responsible for designing implementing and continuously improving the Aseptic Observer Program. This program ensures quality oversight of sterile injectable filling operations supporting compliance with regulatory requirements and maintaining the highest standards of safety identity strength purity and quality (SISPQ).ROLE SUMMARYTheAsepticComplianceManager is a key member of the Quality Assurance Team responsible for designing implementing and continuously improving the Aseptic Observer Program. This program ensures quality oversight of sterile injectable filling operations supporting compliance with regulatoryrequirementsandmaintainingthe highest standards of safety identity strength purity and quality (SISPQ).ROLE RESPONSIBILITIESProgram Design & Oversight: Develop andmaintain the Aseptic Observer Program including audit protocols checklists and documentation requirementsQuality Systems: Implement and enhance quality systems to support aseptic filling operations ensuring alignment with cGMP and regulatory standardsTraining & Development: Lead and improve theasepticbehaviortraining program incorporating industry best practices and contamination control -Functional Collaboration: Partner withManufacturingleadership training leadership and the Contamination Control Strategyownersto address quality risks and process & Audits: Conduct and review aseptic filling audits root cause analyses and corrective/preventive actions (CAPA)Process Improvement: Drive continuous improvement initiatives to enhance efficiency reduce contamination risk and ensure product integrityCulture & Standards: Foster a culture of teamwork productivity and quality excellence ensuring SISPQ is embedded in daily & Reporting: Prepare and presentaseptic behaviormetrics to QUALIFICATIONSEDUCATION:Bachelors degree in sciencepreferred (Microbiology Biology Biochemistry Chemistry Engineering Pharmacy or related science)EXPERIENCE:Minimumof10 yearspreviousexperiencein sterile manufacturing asepticprocessingandquality assurance in a pharmaceutical/biotech SKILLS:Strong knowledge of cGMP FDA/EMA regulations and contamination control audit methodologies root cause analysis and CAPA and capability to aseptically gown andmaintainvarious levels ofcertification to enter and support the manufacturing capability to focus attention on colleaguesbehaviors that in turnleads to higher-than-normal to hold self and others accountable and to encourage colleagues to take personal responsibility for their performance / to coach by providing constructive feedback combined with a willingness to develop and listen aptitude to execute aseptic techniques to a high degree of be able to communicate presentand work well with all facility a positive team environment while performing all tasks in a safe communication leadership and problem-solving duties involve occasional lifting (less than 35 lbs.) reaching and sitting while working atcomputerterminal.#LI-Onsite