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7+ years demonstrated ability in a GMP FDA, cGMP, ISO, or other regulated production environments. Ensure that the Visual Inspection Program operates to meet the requirements of approved production plans at minimum costs within established quality limits and in accordance with FDA, cGMP, ISO, and OSHA requirements.
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Strong technical and business acumen, understanding of regulatory and industry frameworks (ISO, NIST etc.) Knowledge of Azure AD/Active Directory, SSO and MFA and IGA In-depth experience with MS Excel, Visio and PowerPoint Strong Understanding of business process design, security protocols, access controls, andrisk management, including risk analysis, mitigation, and monitoring Good interpersonal skills, and the ability to communicate effectively verbally and written with end users at all levels of the organization.
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Education: Enrolled in a bachelor's or higher level degree program in bioengineering, biotechnology, or sciences (e.g., chemistry, biology, biochemistry, microbiology) General Description: Participate in QC laboratory operations to support GMP testing of materials, intermediates and finished biological products (monoclonal antibodies) under FDA/EU regulations, applicable International Regulations, and BeiGene procedures.
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Hands-on experience with oversight of GMP operations at drug product facilities. The Associate Director, Biologics Quality Assurance will report to the Head Biologics Quality and will be part of a dedicated insulin team at our Petersburg, Virginia state of the art formulation and filling facility.
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A minimum of four years experience in biopharmaceutical manufacturing in a GMP environment Experience with sterile fill finish manufacturing. Knowledge of GMP, regulatory requirements, and industry best practices.
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6) Ensure manufacturing and QC adherence to company policies/procedures, regulatory licenses, industry standards, and GMP regulations. Our client, a leading pharmaceutical company, is currently recruiting an Associate Director of Quality Assurance who will infuse the Quality Assurance Team with their talent, energy and leadership skills.
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Comply with all Plant Safety, GMP, ISO, OSHA procedures, and other programs. Acquire license to operate fork truck, man lift or other equipment. Comply with all Plant Safety, GMP, ISO, OSHA procedures, and other programs.
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Knowledge of industrial control systems and GMP (GAMP5) documentation and practices. Preferable certifications in Microsoft Azure, O365, and network-related credentials. The IT Operations Director is crucial in managing our day-to-day IT operations and ensuring smooth service delivery across the organization.
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Support the mill ISO system by insuring our department quality standards are being met and by being a mill ISO auditor. Keywords: pulp, fiber, utilities, pulp mill, production supervisor, shift supervisor, pulp mill supervisor, pulp supervisor, power supervisor, boiler supervisor, lead boiler operator, area leader, shift leader, area coordinator, area manager, backend supervisor, backend, fiber supervisor, shift supervisor, shift manager, area manager, front line manager, front line supervisor, utilities supervisor, supervisor, fiber shift supervisor, fiber supervisor, boiler, boilers, power.
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Previous experience with combination products, device assembly, pharmaceutical packaging, and filling in aseptic environment. Previous experience with deviation and change management systems including Veeva.
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RESPONSIBILITIES: · Comply with all Plant Safety, GMP, ISO, OSHA procedures, and other programs. SPECIALIZED EQUIPMENT USED:· Hand tools, Voltmeter, power tools, measurement instruments & gauges, computer· Fork truck, etc.
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