- ValSource, Inc. (Rahway, NJ)
- …for a variety of utilities, facilities, and process equipment used in the FDA regulated pharmaceutical and biotech manufacturing industries. Project Manager is ... locations, overseeing on-site validation and equipment qualification activities, and ensuring compliance with FDA , GMP, and other regulatory requirements.… more
- Cipla (Hauppauge, NY)
- …review artwork, packaging materials, and product documentation for accuracy and compliance . Knowledge of pharmaceutical industry regulations related to ... 5:00pm Job Overview: The QA Inspector (Warehouse) ensures the quality and compliance of printed packaging materials and warehouse operations. This includes reviewing… more
- Cipla (Hauppauge, NY)
- …the pharmaceutical industry. Strong knowledge of GMP, regulatory requirements ( FDA , EMA), and pharmaceutical manufacturing processes. High attention to ... integrity, accuracy, and completeness of batch records related to pharmaceutical manufacturing processes, providing assurance that products are produced according… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ... an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Head of Compliance as part of the Global Quality team based in Raritan, NJ. Role… more
- AUROBINDO (Durham, NC)
- … and laboratory GLP/cGMP/GxP complianceEnsuring the accuracy of analytical measurements and compliance with cGMP, US FDA , and other regulatory and corporate ... and validation, with prior supervisory roles being advantageous.Familiarity with pharmaceutical regulatory standards, including USP/ICH/ FDA 21 CFR 210/211,… more
- Cipla (Fall River, MA)
- …management. Preference will be given to candidates with experience in pharmaceutical MDI packaging.Skills/ Competencies Understanding of cGMP, FDA regulations, ... schedules of projects. Monitor packaging processes for adherence to cGMP, FDA , and Cipla's quality standards. Identify and resolve operational inefficiencies,… more
- Merck & Co. (Rahway, NJ)
- …Manufacturing Quality Control, Master Batch Records, Material Selection, Pharmaceutical Process Development, Production Planning, Regulatory Compliance , ... clinical pipeline.-Key Responsibilities:Aseptic Processing: Perform sterile filling operations in compliance with Good Manufacturing Practices (GMP) and Standard Operating… more
- Cipla (Fall River, MA)
- …The Packaging Supervisor ensures compliance with cGMP's, InvaGen Pharmaceutical 's policies,standard operating procedures, and FDA requirements. The incumbent ... Experience One (1) to three (3) years of direct work experience in pharmaceutical packaging. Preference willbe given to candidates with experience in generic … more
- Cipla (Hauppauge, NY)
- …SAP, and other business applications. Strong knowledge of GMP, regulatory requirements ( FDA ), and pharmaceutical manufacturing processes. Prior experience in RX ... product quality is maintained through all phases of manufacturing in compliance with established specifications. Essential Functions: Responsible for monitoring and… more
- Cipla (Fall River, MA)
- …member of the InvaGen Pharmaceuticals Plant Quality Team. This role ensures compliance with both internal and external quality standards at Invagen Pharmaceuticals ... QMS in line with GMP (Good Manufacturing Practice) and regulatory requirements (eg, FDA , ). Maintain and ensure the proper documentation of all quality systems and… more
- Syner-G BioPharma Group (Boston, MA)
- …expertise to streamline operations, enhance quality systems, and ensure regulatory compliance , empowering our clients to navigate complexity and deliver impactful ... commissioning, and qualification of process equipment or systems for compliance with manufacturing requirements and facility fit.Lead start-up activities, including… more
- Aequor (Aliquippa, PA)
- …US raw materials distribution operations, providing data-driven recommendations. Ensure compliance with all required training for staff supporting business and ... (SOPs) and related controlled documents. Interact as needed with the FDA and other governmental inspection agencies, ensuring accurate, professional representation… more
- Tris Pharma (Monmouth Junction, NJ)
- …FDA regulations, current Good Manufacturing Practices (cGMPs) and pharmaceutical supply chain dynamicsWorking knowledge of sustainable procurement practices, ... responsible for multiple facets of the Procurement function within a pharmaceutical manufacturing environment including, but not limited to, purchasing, sourcing,… more
- Cipla (Hauppauge, NY)
- …The incumbent to this role performs and oversees cGMP compliance -based services (commissioning, qualification, validation, consulting, etc.) on equipment and ... facilities and utilities associated with pharmaceutical manufacturing and drug product development. Job Overview Responsible for the coordination of supportive… more
- Lundbeck (Denver, CO)
- …payer access issues (IDNs, Medicare, Medicaid, Commercial) using Lundbeck resources. Pharmaceutical Environment/ Compliance - Apply knowledge of pharmaceutical ... environment, including accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical… more
- Cipla (Central Islip, NY)
- …Hours/ Shift/ Remote 3:00 pm-11:30 pm Responsibilities/ Accountabilities Package pharmaceutical products per Standard Operating Procedures (SOPs) and company ... policies & procedures in compliance with specifications and regulations established for packaging process....Area Standard Operating Procedures and Food and Drug Administration ( FDA ) regulations Ability to communicate effectively and clearly, both… more
- Cipla (Hauppauge, NY)
- …Operate company trucks to transfer materials between facilities. Follow and ensure compliance of safety standards in all Warehouse areas. Maintains assigned areas in ... cGMP policies, documentation and record keeping in accordance with industry and FDA standards and Safety and sanitation regulations. Other duties assigned as… more
- Eisai, Inc (Los Angeles, CA)
- …within local markets and healthcare systems).Experience working with pharmaceutical manufacturer compliance & regulatory requirements.Experience networking, ... Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and...leading demand generation in a manner consistent with the FDA -approved indication to meet or exceed sales objectives. This… more
- Cipla (Central Islip, NY)
- …Shift/ Remote 7:00 am- 3:30 pm Responsibilities/ Accountabilities Package pharmaceutical products per Standard Operating Procedures (SOPs) and company policies ... & procedures in compliance with specifications and regulationsestablishedfor packaging process. Operate automatic filling, labeling, and sealing equipment. Perform… more
- Cipla (Fall River, MA)
- …are not limited to the following : Reviewing and confirming the compliance related to raw materials, inprocess and finished product analytical documents. Monitoring ... during routine operation to ensure adherence to procedure. Confirming and ensuring compliance of the protocols and reports of method validations / verifications /… more
