- Cipla (Hauppauge, NY)
- …generated during batch process and accountability in the batch record . Review of engineering records (temperature and humidity data, calibration ... training assigned and follow company policies, safety requirements, cGMP and SOP's. Review of online batch records , area/equipment logbooks, calibration/PMP… more
- Cipla (Hauppauge, NY)
- …generated during batch process and accountability in the batch record . Review of engineering records (temperature and humidity data, calibration ... batch manufacturing and packaging, as per manufacturing & batch packaging record instructions. Collection of in-process...and follow company policies, safety requirements, cGMP and SOP's. Review of online batch records ,… more
- Cipla (Hauppauge, NY)
- …generated during batch process and accountability in the batch record . Review of engineering records (temperature and humidity data, calibration ... batch manufacturing and packaging, as per manufacturing & batch packaging record instructions. Collection of in-process...and follow company policies, safety requirements, cGMP and SOP's. Review of online batch records ,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …support manufacturing to ensure sterility of the product/process is not compromised.Support batch review & material release in SAP for In-house reagents.Support ... prior to use on the manufacturing floor.Utilize multiple electronic quality systems, batch records and SAP.Work in a team based, cross-functional environment… more
- Cipla (Fall River, MA)
- …but are not limited to the following : Works with Manufacturing/Packaging to deliver timely batch record review across all shifts. Reviews and approval of ... master batch records . Develops appropriate disposition metrics, works...and SOP's. Knowledge of GDP. Creation and maintenance of batch record and cGMP documentation templates. Closure… more
- Merck & Co. (Durham, NC)
- …compliance with cGMP, regulations, and our Company's Quality Management System focusing on batch record review , process/aseptic observations, critical site ... Leads and Supports the Aseptic Observer Program (AOP) and Batch Record Review (BRR) workstreams...Management. Experience with Kneat, Veeva Vault, MEDS, SAP, Electronic Batch Records (MES), Trackwise and GLIMS. RCA… more
- Aequor (Thousand Oaks, CA)
- …for training. The position supports commercial drug substance production and requires cleanroom oversight, batch record review , and acting as a QA liaison ... and use of quality systems. Duties include purposeful presence on the floor, electronic batch record review , SOP revision & approval, work order approval,… more
- Cipla (Central Islip, NY)
- …with safety, quality, productivity, and performance expectations and execution of manufacturing operations. Review batch record after finishing each step for ... to include delivery, in-process samples in a defined schedule. Review and compile the documents generated during the production...during the production of tablets and capsules such as Batch Manufacturing Record (BMR), PQ protocol. Perform… more
- Cipla (Hauppauge, NY)
- …and PM records , Pest control records and contractor related functions). Review of online batch records in terms of completeness of signatures, ... batch record . Monitor facility and product environmental operating conditions. Review of engineering records (temperature and humidity data calibration… more
- Cipla (Hauppauge, NY)
- …and PM records , Pest control records and contractor related functions). Review of online batch records in terms of completeness of signatures, ... batch record . Monitor facility and product environmental operating conditions. Review of engineering records (temperature and humidity data calibration… more