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Strong knowledge of CGMP requirements pertaining to Pharmaceutical Quality Control Laboratories including Data Integrity issues and USP requirements is required. Our clients objective is discovers, develops, and markets vertical integration of pharmaceutical manufacturing and private label skincare.
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5 to 7 years of quality assurance experience in the pharmaceutical industry providing oversight to Manufacturing Operations, QC, and other cGMP areas. Performs independent technical review of documentation including Batch Production Records during and post-execution of cGMP activities.
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We are leading the way with unmatched expertise in current Good Manufacturing Practices and sterile pharmaceutical manufacturing, and the highest quality and safety standards so hospitals can more confidently and reliably focus on patient care nationwide.
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Electronic Records & Electronic Signatures (Part 11), cGMP Bachelors Degree with a concentration in IT/Computer Systems 4 to 5 years of experience in Pharmaceutical industry or computer systems management Good knowledge in cGMP environment.
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Must be willing to work in a pharmaceutical packaging setting. This role works in a cGMP laboratory or manufacturing environment, where personal protective equipment is required, which may include uniforms, lab coats, safety glasses, respiratory protective equipment, hearing protection, etc.
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EDUCATION Bachelor of Science in Analytical Chemistry, Chemistry, Pharmaceutical Sciences or a closely related area of studyQUALITIES Excellent interpersonal skills and the ability to communicate well orally and in writing to all levels of the organization.
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Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel) in 2017.
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Specific expertise with Plumbing systems serving hotels, student housing, laboratories, power plants, Cogeneration facilities, manufacturing facilities, clean rooms, cGMP facilities and process systems for Pharmaceutical and microelectronics facilities is desired.
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Qualifications BA/BS degree in life sciences or related field, or an equivalent combination of education & experience Minimum of 7 years of QA and/or related quality experience in manufacturing, utility and/or packaging systems, preferably in the pharmaceutical or medical device field Demonstrated expertise in Regulations & quality systems (e.g. product disposition, DV/CAPA, Change Control, Audits, Supplier Management, Project Management, Validation, etc.
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Operations experience in pharmaceutical manufacturing to cGMP standards including extensive knowledge of regulatory guidelines and validation practices. Knowledge of suppliers, industry trends and emerging players in global pharmaceutical manufacturing services.
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Extensive knowledge of cGMP requirements and regulations for pharmaceutical manufacturing. Minimum 5 years engineering experience in a pharmaceutical industry setting with a focus on aseptic processing and lyophilization.
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Knowledge in cGMP as related to records and documentation in a pharmaceutical manufacturing environment preferred. The QA Technician is responsible for providing quality support to the manufacturing floor, auditing batch production documentation, dispositioning intermediates and equipment after cleaning, performing in process checks, reviewing and approving incident reports, revise quality documents (e.g. SOP, protocols, methods), and ensuring adherence to cGMP.
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In the Formulation Technician I position, you will be responsible for performing operations related to the manufacturing of pharmaceutical products through equipment set-up, operation, clean up and maintenance in compliance with all regulatory cGMP requirements and company policies and procedures.
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Review and approve all facility and equipment changes that may affect cGMP. QUALIFICATIONS AND REQUIREMENTS: Bachelor's degree in science or related field; Master's degree preferred 8+ years of experience in Quality Control or Quality Assurance in pharmaceutical manufacturing and 5+ years of experience leading Quality teams.
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Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. Participate in Response Development to Regulatory Inspection Observations and execute corrective actions recommended as a part of cGMP/Regulatory compliance.
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