Company Description
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Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
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We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.
Job Description
Responsibilities:
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As a Validation Engineer within the Mold & Capital Tooling Organization, you'll play a pivotal role on a global enterprise team, collaborating with various sites around the world. In this role, you'll facilitate or perform critical validation & qualification activities, ensuring the seamless release of high-quality injection molded components that drive our mission forward.
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Ensure proper qualification and validation of suppliers and their processes, ensuring supplier meets the requirements for producing high-quality, reliable products.
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Developing and executing validation plans, conducting audits, and managing the overall PPAP process to ensure compliance with ISO 13485/ Medical standards.
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Write, review and approve validation change controls and validation protocols IQ OQ PQ PV standard operating procedures, standard calibration methods, standard test methods, specifications CAPAs and exception reports.
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Strong documentation skills - Accurately recording and managing validation processes in compliance with internal SOPs and external regulations.
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Review test results and measurements to identify discrepancies.
SPC (Statistical Process Control). -
Knowledge on ISO 13485, FDA GMP, ISO 14971, FDA CFR 820.
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Clean Room experience and medical prod mfg exp (added advantage).
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Communicates with stakeholders, obtains stakeholder engagement to ensure the end products or processes will solve the business problems.
Requirements:
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Bachelor's degree with a minimum of 5-7 years of experience in a regulated environment, OR an advanced degree with a minimum of 3 years of experience.
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Minimum of 5 years of professional experience in a relevant field.
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Experience with Agile PLM and SAP or BPCS ERP systems.
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Experience with CAD model with use of Solid works or AutoCAD.
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Experience with NPI and design transfers deliverables for injection moulded components.
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Experience within highly regulated industry.
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Hands on experience within production and enterprise environment.
Additional Information
All your information will be kept confidential according to EEO guidelines.
