- Merck & Co. (Millsboro, DE)
- … Safety Management, Operations Management, Process Improvements, Process Manufacturing, Product Handling, Recordkeeping, Regulatory Compliance , Safety ... people that make our products. We work in the manufacturing plants with a " Safety First, Quality Always" mindset striving for continuous improvement. We work in the… more
- Insmed Incorporated (NJ)
- …risk minimization and pharmacovigilance measures in compliance with regulatory requirements. Develop/provide input to product Benefit-Risk Assessments, ... the medical expert for assigned products and maintain current knowledge of assigned product portfolio and safety profiles. This individual will provide the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and in compliance with Novo Nordisk and FDA requirements Responsible for Product Safety compliance across all Patient Support Programs (including contact ... Programs team, Commercial Operations, Commercial, NNI IT and Telephony, Medical Information, Product Safety , Regulatory , Quality, Legal, Privacy and Finance.… more
- Bayer (MN)
- …academics & other key influencers on seed, trait & systems field trials"; REGULATORY COMPLIANCE / STEWARDSHIP Adheres to company Trait Stewardship requirements ... diverse minds to make a real difference, there’s only one choice. Product Agronomy Specialist III-Minnesota YOUR TASKS AND RESPONSIBILITIES The territory for this… more
- Eisai, Inc (Philadelphia, PA)
- …Engineering functions for artwork control and approval.Ensure consistency of labeling across product lines and compliance with Eisai policies and procedures and ... environments and requirementsSolid knowledge of and demonstrated ability to apply regulatory guidelines pertaining to product labeling and ICH guidelines.Strong… more
- Cipla (Fall River, MA)
- …time loss during any machine breakdown Prepare, review and update GMP documents to meet regulatory compliance and quality of product Prepare the facility and ... carried out are as per requirement of cGMP & safety to meet the quality and packaging targets in...identification and analysis. Capable of handling and participating in compliance and regulatory audits at the local… more
- Merck & Co. (Rahway, NJ)
- …and drug product container closure systems including mold qualification and regulatory compliance .- To act as master data stewards and support enterprise ... trouble shooting and continuous improvement initiatives to guarantee the robustness and compliance of our company's product portfolio across the internal and… more
- Syner-G BioPharma Group (Boston, MA)
- …and hands-on expertise to streamline operations, enhance quality systems, and ensure regulatory compliance , empowering our clients to navigate complexity and ... automation systems.Maritime facilities background (preferred).Familiarity with GMP environments and regulatory compliance (preferred).LEED certification, PE license, or… more
- Cipla (Hauppauge, NY)
- …for printed packaging materials to ensure accuracy, compliance with regulatory requirements, and alignment with product specifications. This includes labels, ... proper storage, handling, and inventory of printed packaging materials to maintain product quality and compliance . Ensure proper storage, labeling, and inventory… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …from early research through IND-enabling studies and into clinical development, ensuring regulatory compliance and scientific rigor in support of our pipeline ... programs, including off-target effects, immunogenicity, insertional mutagenesis, and long-term safety .Participate in the development of target product profiles… 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 ... with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under manufacture, we have a… more
- Cipla (Fall River, MA)
- …with purchase, production, etc. to support manufacturing effectively and ensure compliance to cGMP and safety .Essential Duties and Responsibilities: Maintain ... of new products material to tech transfer during new product meetings Monitor the store operations for compliance... to cGMP and set standards to meet the regulatory requirement and to ensure audit readiness. Ensure proper… more
- Cipla (Fall River, MA)
- …EMA). Support risk assessments and help mitigate any potential quality risks to product safety and compliance . Familiar with pharmaceuticals operation ... Request and Environmental monitoring etc. Preparation and review of the Annual Product Quality Review. Fulfil the requirement of regulatory submission while… more
- Merck & Co. (Rahway, NJ)
- …Records, Material Selection, Pharmaceutical Process Development, Production Planning, Regulatory Compliance , Shift Work, TeamworkPreferred Skills:Current ... or reduce risk to schedule adherence. Compliance : Identifies and addresses compliance , environmental, safety , and process deviations as appropriate while… more
- Merck & Co. (Rahway, NJ)
- …for distribution and logistics of human health Drug Substance, Drug Product and Finished Goods globally.- The Packaging Technical Operations organization aims ... and 3rd party logistics sites, supply chain and technology teams, and regulatory and project leaders. The successful candidate will demonstrate ownership and make… more
- Merck & Co. (Durham, NC)
- …Management, Pharmaceutical Process Development, Production Planning, Quality Management, Regulatory Compliance {+ 4 more}Preferred Skills:Current Employees ... documents) to support project and future operations. Identifies and addresses compliance , environmental, safety , and process deviations as appropriate while… more
- Cipla (Fall River, MA)
- …safe and efficient execution of their job duties, while ensuring product compliance to established standards.Essential Duties and Responsibilities: Understanding ... machines and area as per batch to batch and product to product change over. Performing operations...time, ensuring accuracy and completeness. Adhering to all cGMPs, compliance / regulatory mandates and quality requirements. Complying with… more
- Cipla (Fall River, MA)
- …safe and efficient execution of their job duties, while ensuring product compliance to established standards.Essential Duties and Responsibilities: Understanding ... machines and area as per batch to batch and product to product change over. Performing operations...time, ensuring accuracy and completeness. Adhering to all cGMPs, compliance / regulatory mandates and quality requirements. Complying with… more
- Cipla (Fall River, MA)
- …safe and efficient execution of their job duties, while ensuring product compliance to established standards.Essential Duties and Responsibilities: Understanding ... machines and area as per batch to batch and product to product change over. Performing operations...time, ensuring accuracy and completeness. Adhering to all cGMPs, compliance / regulatory mandates and quality requirements. Complying with… more
- Cipla (Fall River, MA)
- …safe and efficient execution of their job duties, while ensuring product compliance to established standards.Essential Duties and Responsibilities Understanding ... machines and area as per batch to batch and product to product change over. Performing operations...time, ensuring accuracy and completeness. Adhering to all cGMPs, compliance / regulatory mandates and quality requirements. Complying with… more
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