- 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
- Cipla (Hauppauge, NY)
- …and associated documentation meet regulatory requirements from agencies such as the FDA , EMA, and other relevant authorities. Review, creation and revision of BPRs, ... audit-ready and fully compliant for both internal and external audits (eg, FDA , GMP inspections). Assist audit teams by providing required batch documentation and… 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 (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
- Aptyx (Taunton, MA)
- …secondary operations on medical devices in compliance with ISO 13485, ISO 9001, FDA regulations, and Good Manufacturing Practices (GMP). This role is critical to ... packaging, and secondary manufacturing operations as assigned. Follow all GMP, FDA , ISO, environmental, and company quality system requirements. Adhere to… more
- Bayer (WA)
- …Medical Inquires in collaboration with Medical Communications;Adherence to SOP and FDA guidance for distribution of scientific information;Adherence to SOP and ... Pharmacology, Pharmacy, Medicine, Nursing or equivalent experience is preferred;Working knowledge of FDA , OIG requirements;A minimum of 1 year MSL experience or 2… 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
- Formation Bio (New York, NY)
- …overall quality assurance practices.Responsibilities Ensure compliance with global regulations (eg, FDA , EMA, ICH) and internal SOPs, Policies and Work Instructions ... or biotechnology manufacturing and testing Deep understanding of GMP expectations (eg, FDA , EMA, and ICH) and a commitment to patient safety Excellent communication,… more
