- Cipla (Fall River, MA)
- …and computer system. Preparation and qualification of e-batch record & e-Log Book . Knowledge of cleaning validation and process validation. Knowledge in project ... handle with new equipment. Knowledge of URS, FDS, DQ, HDS, SDS, FS, validation plan, FAT, SAT, IQ, OQ,PQ, validation certificate, PIR,RTM, electronic signature, electronic reports. Knowledge of 21 CFR and implementation. Knowledge of automation of… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …areas they may be expected to perform other tasks suchs as: document and log book reviews, keeping up to date on trainings, and supporting other ad hoc requests as ... needed. Incumbent will be expected to work in a fast-paced environment where priorities can change quickly, while adhering to our cGMP processes and documentation standards. Working in the cleanroom areas may require wearing: hairnet, beard cover,… more
- Insmed Incorporated (NJ)
- …of regulatory documents and meeting materials (eg, meeting requests, briefing books , cover letter forms, etc.) ensuring clarity, accuracy, and consistency Lead ... document workflows throughout document lifecycles for regulatory documents, including creation, review, approval, revision, distribution, and archival Assist in preparing and organizing all comments received from regulatory agencies and manage and/or track the… more
- Cipla (Central Islip, NY)
- …and company Standard Operating Procedures (SOP). Accurately and legibly document inapplicableLog Books Determinewhen to stop a line related to safety or quality. ... Operate automatic packaging equipment. Document packaging activities. Feedfilling equipment. Palletize finished products. Segregate wasteproductsand materials. Return unused material/product. Participate in safety related programsand orsafety teams as needed.… more
- Insmed Incorporated (NJ)
- …or oversee authorship of clinical sections of regulatory submissions (INDs, briefing books , BLAs, NDAs, etc.) and represent the company at regulatory meetings ... including presentation at Advisory Committee Meetings.Prepare safety charters, DMC charters, or other specific management plans and manuals in a cross-functional team.Represent the company to external stakeholders supporting the conduct of clinical trials,… more
- Syner-G BioPharma Group (Boston, MA)
- …required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, ... stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus. Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing… more
- Syner-G BioPharma Group (Boston, MA)
- …required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, ... stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus.Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing… more
- Cipla (Fall River, MA)
- …of p reparation of BMR and eBMR. Knowledge of p reparation of SOP and eLog books . During audit part of team. Planning of batches as per production plan. Knowledge of ... audits and compliance . Professional and Behavioral Competencies Proficiently speak English as a first or second language Ability to understand and analyze complex data sets. Knowledge of statistical packages is a plus. Knowledge of good manufacturing… more
- Eisai, Inc (Nutley, NJ)
- …to Clinical Pharmacology expertise and content to regulatory documents (eg briefing books , INDs, NDAs etc.) and represent Clinical Pharmacology in discussions with ... Health Authorities.Reviews 3rd party work products and deliverables to approve payment of invoices and resolve discrepancies. Requirements A PhD, MD or PharmD degree with at least 5 years of pharmaceutical industry related experience as a Clinical Pharmacology… more
- Marshall and Sterling Inc (Yorktown Heights, NY)
- …business growth, expanding existing commercial lines accounts, and maintaining a strong book of business. This position will be based out of Marshall+Sterling's ... MAJOR RESPONSIBILITIES Drive new business growth while maintaining and expanding your book of business. Proactively build and manage a pipeline of prospects to… more
