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Scope of Function:Responsible for leading the development, implementation, and maintenance of Quality Systems in support of combination drug products to include, but not limited to: Policies and Procedures, Deviations, CAPA’s, Document and Change Controls, Validation, Internal Auditing, Supplier and Material Management, and Training.
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Knowledgeable of FDA regulatory requirements applicable to oral dosage pharmaceuticals. Write process validation protocols, sampling plans for all product process validation studies or activities (may include preclinical and clinical manufacturing, as needed.
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As a Microbiologist you will apply cGLP, cGMP, ANSI, AAMI, ISO, EUMDR, FDA and USP guidelines to the bioburden, cytotoxicity, bacterial endotoxin, and biocompatibility analysis of orthopaedic implants and surgical instruments for Leesburg, VA facility.
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Develop validation documents per FDA cGMP and GAMP standards, functional specifications, design specifications and requirements trace matrices. Prepare and execute validation protocols (AIQ, IQ, OQ) for 21 CFR Part 11 compliance per FDA requirements.
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We provide commissioning, qualification, validation, start-up, project management and other consulting services associated with operational readiness to FDA regulated and other mission-critical industries.
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We’re looking for a senior Verification & Validation Engineer in Bioinformatics to increase our team’s performance and add value to the Bioinformatics department in SMEDIX San Diego. You’ll work with bioinformatics SQA engineers and members of the bioinformatics group to develop test cases that ensure the quality of bioinformatics software used in FDA regulated environments.
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In-depth knowledge of cGMP's, especially FDA regulations CFR Parts with preferred understanding of regulations for computerized systems Strong understanding and operating awareness of working in a pharmaceutical company.
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Experience in FDA and/or Global regulated environment with good understanding of GCP , GLP and Risk based validation strategy. Responsibilities: looking for a pure validation resource with periodic review, audit experience.
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Ability to understand and follow FDA regulations, ISO requirements, and BD Quality Systems. + Provides technical support for developing new test methods for calibration or process validation studies as part of new product development, design transfer, cost reduction, and safety programs.
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Perform all duties and all quality assurance / validation activities according to the applicable guidelines, i.e. FDA, GMP, ICH etc. Support validation and manufacturing operations by applying measurement science, mathematics, and physics to develop, document, and maintain measurement systems, procedures, and methods for dimensional, optical, physical, mechanical, environmental, and/or chemical inspection, measurement, and test equipment.
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Excellent computer system validation, CAPA, Deviation Documentation, and Auditing skill. Advanced-level understanding of quality management systems, including the writing of policies and procedures, auditing techniques and FDA regulations for clinical trial software.
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XML documents and reviewer’s guides per CDISC and FDA specifications and guidelines using standard tools and templates. Experience in development and validation of CDISC SDTM and ADaM data models by transforming raw data into standard domains and development and validation of Tables/Listings/Figures.
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Design and execute implementations for PDM, PLM, Change Management, and Migrations, Process Validation - IQ, OQ, PQWork closely with project managers ensuring project scope is meant and change control is initiated as needed.
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Responsibilities: Develop and implement validation plans for new and existing products, considering design, manufacturing processes, equipment, and software in compliance with FDA regulations and ISO standards.
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Knowledge of biologics regulatory guidelines including FDA/ICH on risk management, technology transfer and process validation. Strong background and subject matter expertise in purification unit operations including column chromatography, filtration (UF, DF, TFF), harvest and viral clearance validation in the manufacture of recombinant proteins and antibodies.
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