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Minimum of 9+years' experience in validation, biological quality assurance and/or quality control in an FDregulated biotechnology or pharmaceutical company with progressive levels of responsibility.
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Manage the facility support / engineering / maintenance staff responsible for power plant, security, pest control, custodians, landscaping, event planning, preventive and on-demand maintenance, calibration, fire suppression systems including non-water systems, energy monitoring, facility and infrastructure construction projects in a GMP pharmaceutical manufacturing site.
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Advanced knowledge of pharmaceutical, manufacturing and laboratory systems and equipment. Required Competencies- Knowledge, skills, and abilities Advanced knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.
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Advanced knowledge of pharmaceutical, manufacturing and laboratory systems. Understanding of investigations, deviations and CAPA management in a regulated pharmaceutical industry. Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.
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Proven and relevant regulatory affairs experience in pharmaceutical, vaccine, or biological products; or related fields. Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks.
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Completes all qualification and validation documentation with accuracy, completeness and compliance to Celgene standards. Experience in the qualification of cell therapy equipment a plus. Completes all qualification and validation documentation with accuracy, completeness and compliance to Celgene standards.
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Completes all qualification and validation documentation with accuracy, completeness and compliance to Client standards. The Equipment Validation Engineer supports the successful implementation of various process/lab equipment at multi-use sites through interaction with internal customers and external service providers.
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Manage execution / authoring of CMC documentation (Module 1 , 2 and 3) for life cycle management - post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems.
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Founded in 1987, Canfield Scientific, Inc. is a core imaging lab providing custom photographic systems, image monitoring, and centralized analysis services for the pharmaceutical, biotechnology and cosmetics industries supporting global clinical trials providing primary endpoint data and supporting documentation.
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At least 1 year of relevant experience in the pharmaceutical, biologics, microbiology, sterile manufacture, medical device industry or related industry. Executes and follows SOPs, WPs, and quality policies and peer review and archive analytical data in lab documentation systems.
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Description The Document Control Specialist is responsible for ensuring that all site documentation is in compliance with all relevant quality system and regulatory requirements. 5+ years of Quality Control/Quality Assurance/Document Control experience in a manufacturing plant is preferred; pharmaceutical manufacturing experience is a plus.
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Is accountable for inspection readiness of external data documentation filed/archived in Trial Master File (TMF) according to applicable Daiichi Sankyo and regulatory requirements. 4 or more years Clinical data management experience in a medical device, pharmaceutical company, or similar environment (e.g., CRO); oncology, immunology, or complex disease therapeutic area is a must.
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Minimum 5 years of Medicaid Rebate or rebate experience within a pharmaceutical company, state, and/or state agency or as a Medicaid consultant. Manage third-party vendor by meeting regularly, managing dispute assignments, tracking progress, managing and providing requested backup needed to resolve disputes, including historical information, claims level data, and any other supporting documentation needed for dispute resolution.
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Serve as the CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones for assigned products through the product lifecycle as needed for product in-license/due diligence review, product divestment and product withdrawal.
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Canfield Scientific, Inc. is a core imaging lab providing custom photographic systems, image monitoring, and centralized analysis services for the pharmaceutical, biotechnology and cosmetics industries supporting global clinical trials providing primary endpoint data and supporting documentation.
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pharmaceutical documentation jobs in Madison, NJ
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