- Merck & Co. (Rahway, NJ)
- …using operational excellence tools and ensuring alignment with global regulatory requirements (eg, FDA 21 CFR Part 820, ISO 13485, ISO 14971). - This position will ... requirements for medical device and drug combination products (eg, FDA 21 CFR Part 820, ISO 13485, ISO 14971)...to identify gaps against internal standards, regulatory expectations (eg, FDA , EMA), and industry best practices, generate action plans… more
- ValSource, Inc. (Rahway, NJ)
- …variety of utilities, facilities, and process equipment used in the FDA regulated pharmaceutical and biotech manufacturing industries. Project Manager is responsible ... validation and equipment qualification activities, and ensuring compliance with FDA , GMP, and other regulatory requirements. ResponsibilitiesOn-Site Project Management:… more
- Syner-G BioPharma Group (Boston, MA)
- …and/or technical experience required.Experience with cGMP Manufacturing within an FDA -regulated manufacturing company.Knowledge of cGxP Quality Systems within an ... FDA -regulated manufacturing company.Knowledge of FDA regulations and guidance or applicable regulatory standards and practices.Proficient with MS Office suite, MS… more
- AUROBINDO (Durham, NC)
- …accuracy of analytical measurements and compliance with cGMP, US FDA , and other regulatory and corporate requirements.Conducting troubleshooting and investigations ... supervisory roles being advantageous.Familiarity with pharmaceutical regulatory standards, including USP/ICH/ FDA 21 CFR 210/211, CFR 11 & CFR 820/ISO… more
- Cipla (Fall River, MA)
- …schedules of projects. Monitor packaging processes for adherence to cGMP, FDA , and Cipla's quality standards. Identify and resolve operational inefficiencies, ... experience in pharmaceutical MDI packaging.Skills/ Competencies Understanding of cGMP, FDA regulations, and pharmaceutical packaging processes. Experience in SAP… more
- Cipla (Hauppauge, NY)
- …cGMP policies, documentation and record keeping in accordance with industry and FDA standards and Safety and sanitation regulations. Other duties assigned as ... or ability to obtain certification. Basic knowledge in FOOD/OTC or another FDA Regulated Warehouse/materials environment Preference will be given to candidates with… more
- Aequor (Hicksville, OH)
- …cGMP's, company policies, and all other quality or regu-latory requirements (OSHA, DEA, FDA , EMEA, ANVISA, HS&E, etc.). Ensures all work is performed in a safe, ... effective manner, and in compliance with the appro-priate industry and regulatory ( FDA , DEA, OSHA) standards, and Departmental, Plant, and Corporate quality and… more
- Cipla (Hauppauge, NY)
- …Ensure that the artwork complies with all relevant regulatory guidelines (eg, FDA , EMA) and industry standards, including proper labeling, dosage information, and ... understanding of Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), FDA and EMA regulations. Familiarity with Microsoft Office Suite (Word,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy ... and best practices across the organization, ensuring consistency and compliance with FDA , EMA, and other regulatory guidelines Conduct regular audits of GxP… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy ... to Novo Nordisk products and in compliance with Novo Nordisk and FDA requirements Responsible for Product Safety compliance across all Patient Support Programs… more
- Insmed Incorporated (NJ)
- …to submission.Ensure adherence to global regulatory authority technical requirements ( FDA , EMA, Health Canada, MHRA, etc.) for electronic submissions.Maintain ... tools (eg, Lorenz, GlobalSubmit, Extedo, or equivalent).Strong knowledge of FDA , EMA, and ICH electronic submission standards and guidance.Excellent organizational… more
- Eisai, Inc (Los Angeles, CA)
- …of NASs and then leading demand generation in a manner consistent with the FDA -approved indication to meet or exceed sales objectives. This will be accomplished by ... conveying complex clinical information to customers and key stakeholders regarding FDA -approved indications of this novel therapy. The individual will implement and… more
- Tris Pharma (Monmouth Junction, NJ)
- …(SOPs), current Good Manufacturing Practices (cGMPs) and Food and Drug Administration ( FDA ) standards. She/he also provides and monitors the continuous flow of ... is cleaned to meet production schedule and in accordance to strict SOP, FDA and cGMP standardsSupports and assists with daily cleaning functions, as needed (vaults,… more
- Merck & Co. (Rahway, NJ)
- …strategy.Knowledge of US and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA Human ... Factors guidance, ISO 14971, 11608 and 11040, EN 62366, Council Directive 93/42/EEC, etc.Proven track record of applying analytical skills in product design, development, and validationSelf-motivated with ability to work independentlyProven ability to lead… more
- Formation Bio (New York, NY)
- …and resource allocation. Ensure all clinical trials comply with ICH-GCP, FDA regulations, and other applicable regulatory standards. Champion proactive risk ... and managing complex, multi-center clinical trials. In-depth knowledge of ICH-GCP, FDA regulations, and global clinical trial guidelines. Strong strategic thinking… more
- Cipla (Fall River, MA)
- …Manufacturing Practices (GMP)/Good documentation Practices (GDP), USP monograph requirements, FDA & ICH guidance requirements, etc. Technical Knowledge and Computer ... pH meter, Stability chambers, etc. Strong knowledge on USP monograph requirements, FDA & ICH guidance requirements, etc. Must be able to influence decision… more
- Legend Biotech USA, Inc. (Baltimore, MD)
- …ethical standards and will adhere to the regulatory requirements of the FDA and other government agency guidelines, without exception. This position will report ... exception, with all corporate policies and procedures as well as all applicable FDA and OIG legal standards and requirements as well as PhRMA guidelinesSpear-head… more
- Insmed Incorporated (NJ)
- …and lab business processes is preferred.Solid working knowledge of CSV guidelines and FDA /EU regulations: 21 CFR Part 11, Annex 11, GAMP 5, GMPs, Good Clinical ... with Veeva QualityDocs /QMS is preferred.Knowledge and understanding of the FDA Computer Software Assurance (CSA) fundamental concepts.Basic understanding of data… more
- Insmed Incorporated (San Diego, CA)
- …understanding of document management principles.Solid working knowledge of CSV guidelines and FDA /EU regulations:21 CFR Part 11, Annex 11, GAMP 5, Good Clinical ... Practices, GMPs, Data Integrity.Knowledge of the FDA Computer Software Assurance (CSA) fundamental concepts.Strong technical writing skills for authoring, reviewing… more
- Insmed Incorporated (NJ)
- …is preferred.Experience with Veeva QualityDocs /QMSSolid working knowledge of CSV guidelines and FDA /EU regulations: 21 CFR Part 11, Annex 11, GAMP 5, Good Clinical ... Practices, Data Integrity.Knowledge of the FDA Computer Software Assurance (CSA) fundamental concepts.Strong technical writing skills for authoring, reviewing and… more
