Christopher Pinto
Manufacturing Supervisor @Sharp Sterile Manufacturing
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WORK HISTORY
Manufacturing Supervisor @Sharp Sterile Manufacturing
Lee, MA, US
Oversee personnel and activities related to the production process ensuring compliance with cGMPs and BSM-specific policies and procedures• Ensure that production schedules are achieved, operating within approved budgets and meeting all necessary cGMP, Quality and Safety requirements• Coach, mentor, provides management direction to leads, production employees and assure training and evaluate performance to maximize the efficiency, rewarding and disciplining employees, addressing complaints, resolving problems, interviewing, hiring and training new employees• Maintain and report metrics to evaluate performance of manufacturing unit, compile shift information and accurately convey information to oncoming shifts, management team and support groups• Provide technical expertise and resources, to component preparation, formulation, filling, collaborating and coordinating with production, engineering, technical services and other groups• Complete all documentation associated with the process, assure adherence to current Good Manufacturing Practices, company policies and regulations• Act in place of manufacturing manager in their absence, demonstrate BSM values and behaviors at all times and assist management with reports, projects, and other assigned duties• Report and investigate Quality deviations and events, report and participate in the investigation of events, excursions, deviations and safety incidents• Carryout all duties in compliance with regulatory and professional agencies, including but not limited to state, FDA, OSHA and EU regulations, or otherwise as applicable• Maintain continued education and proficiency in field through education, literature and seminars, attend and complete all mandatory training procedures
EDUCATION
University of Mysore
Bachelor of Science (B.Sc.)
Vijaya College
Bachelor of Science (B.Sc.)
University of Michigan
Certificate Course
SKILLS
ABOUT CHRISTOPHER PINTO
Highly focused, team-oriented processing professional with credible experience in the Pharmaceutical industry, equipped with a research background in semi-solid and liquid dosage forms With over 10 years of experience in Aseptic and non Aseptic processes. Areas of expertise include production, planning, processing, in-process quality control, and packaging of Injections, Tablets, Capsules, Ophthalmic Eye Care, Oral and Topical drug products Seeking a position with leadership responsibilities including problem-solving, planning, organizing and achieving the organizational goals Specialties: Experience in cGMP, GLP, SOP, CAPA, Lean, Kaizen, processing, liaising with analytical Support, project management, material management, quality, engineering, and other functional areas to meet the objectives Proven ability to develop and manage multiple research programs with strong technical experience in pre-formulation, formulation, process development, optimization, and technology transfer Excellent with authoring documentation for product development, scale-up activities, registration, tech transfer, stability protocols, manufacturing and packaging batch records for development and clinical trial batches Proficiency in FDA regulations, QBD, SAP, MS Office, DOE’s, QTA\'s, QTPP\'s, process optimization and validation of developmental batches, development of NCE, ANDA, NDA for pre-clinical and clinical trials Strong organizational leadership, interpersonal, organizational and communication skills, proven technical competency, mechanically inclined, troubleshooting, multi-tasking and a strong commitment to teamwork
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