Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients' lives by bringing new biopharmaceuticals to market.Key Responsibilities
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Coordinate the Quality System Compliance team and its related activitiesManage the Self-Inspection processManage the GMP documentation on the digital electronic system TrackWiseOversee the periodic monitoring and analysis of quality KPIsManage the CAPA Management processManage the alignment of internal procedures with corporate policiesManage the risk management process and the risk registerManage the GMP paper documentations archive and their sending to customersAct as a subject matter expert during inspections by regulatory agencies, corporate teams, and clients and support in their preparing
Qualifications & Experience
Master Degree in a scientific discipline (e.g., Biology, Chemistry, Biotechnology, Pharmacy)5+ years of experience in a documentation control or quality system/assurance role within a GMP-regulated environment (pharmaceutical or biotechnology industry)Experience as a people leaderKnowledge of GMP and Data Integrity standardsProficiency with Electronic Document Management Systems and Office Windows systemExceptional attention to detail and organizational skillsCommunication and interpersonal skillsProfessional working knowledge of English (both written and spoken)
AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement.AGC Biologics is an equal opportunity employer. xjrgpwk All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.#J-18808-Ljbffr