- Cipla (Hauppauge, NY)
- …of rejected material generated during batch process and accountability in the batch record . Review of engineering records (temperature and humidity data, ... (eg, weight, thickness, hardness, disintegration, friability, etc.) as per manufacturing batch record instructions. Ensure cleaning of manufacturing and… more
- Cipla (Hauppauge, NY)
- …of rejected material generated during batch process and accountability in the batch record . Review of engineering records (temperature and humidity data, ... follow company policies, safety requirements, cGMP and SOP's. Review of online batch records , area/equipment logbooks, calibration/PMP records etc. Ensure… more
- Cipla (Hauppauge, NY)
- …of rejected material generated during batch process and accountability in the batch record . Review of engineering records (temperature and humidity data, ... follow company policies, safety requirements, cGMP and SOP's. Review of online batch records , area/equipment logbooks, calibration/PMP records etc. Ensure… more
- Cipla (Hauppauge, NY)
- …(eg weight, thickness, hardness, disintegration, friability, etc.) as per manufacturing batch record instructions. Perform room and equipment checks (where ... during batch process and accountability in the batch record . Monitor facility and product environmental...records and contractor related functions). Review of online batch records in terms of completeness of… more
- Cipla (Hauppauge, NY)
- …(eg, weight, thickness, hardness, disintegration, friability, etc.) as per manufacturing batch record instructions. Perform room and equipment checks (where ... during batch process and accountability in the batch record . Monitor facility and product environmental...records and contractor related functions). Review of online batch records in terms of completeness of… more
- Cipla (Fall River, MA)
- …(eg, weight, thickness, hardness, disintegration, friability, etc.) as per manufacturing batch record instructions. Conduct room and equipment checks (where ... during batch process and accountability in the batch record . Monitor facility and product environmental... records and contractor related functions. Assess online batch records in terms of completeness of… more
- Cipla (Fall River, MA)
- …materials and production lines. Conducting process checks and recording in batch manufacturing record . Controlling machine operations with minimum rejections ... maintenance and calibration. Manufacturing and filling of products as per Batch Manufacturing Records and SOP. Maintaining inventory of machine parts, tools and… more
- Cipla (Fall River, MA)
- …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)
- …with cGMP, regulations, and our Company's Quality Management System focusing on batch record review, process/aseptic observations, critical site review, critical ... Leads and Supports the Aseptic Observer Program (AOP) and Batch Record Review (BRR) workstreams for the...Management. Experience with Kneat, Veeva Vault, MEDS, SAP, Electronic Batch Records (MES), Trackwise and GLIMS. RCA… more
- Endo International (St. Louis, MO)
- …+ Work with production in recording correct DOM + Serve as a resource regarding batch record linkage for all special products + Prepare shipping schedule and ... Update items in BPCS for the in process lab personnel + Review batch records as a backup or if required for shipping needs **MINIMUM REQUIREMENTS:**… more
- Endo International (Hobart, NY)
- …+ Able to read, comprehend, and make appropriate alterations to documents such as batch records , quality agreements, SOPs, etc. + Actively takes the lead in ... monitor the quality of all manufacturing and packaging activities including executing batch manufacturing and packaging records in accordance with specified… more
- Cipla (Fall River, MA)
- …Control Room. Receive approved and executed documents related to SOPs, batch records , validation and qualification protocols, specifications, training ... ensuring GDP. Issue the approved and executed documents related to SOPs, batch records , validation and qualification protocols, specifications, training … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …prior to use on the manufacturing floor.Utilize multiple electronic quality systems, batch records and SAP.Work in a team based, cross-functional environment ... assigned tasks.Strong proficiency utilizing relevant manufacturing applications (SAP), electronic batch records (EBR), and quality systems.Utilizes tools within… more
- Endo International (Raleigh, NC)
- …to manufacturing responsibilities. This includes understanding and following all applicable batch records , standard operating procedures and work instructions, ... boards, indicators, and HMI displays (for PLC and DCS controls) following applicable batch records , procedures, and good documentation practices. + Operates and… more
- Formation Bio (New York, NY)
- …Lead the quality review process, ensuring the effective review and approval of batch records , release testing, and other quality-related documentation. Foster a ... implementation, and upkeep of quality systems and procedures, including SOPs, batch records , and quality metrics.standard operating procedures (SOPs) pertaining… more
- Aequor (Thousand Oaks, CA)
- …training. The position supports commercial drug substance production and requires cleanroom oversight, batch record review, and acting as a QA liaison during ... and use of quality systems. Duties include purposeful presence on the floor, electronic batch record review, SOP revision & approval, work order approval, and… more
- Curia (Springfield, MO)
- …Good Documentation Practices when completing GMP related documents such as Master Batch Records , SOP and Operating Manual requirements, equipment operation, ... trained on the changes. Ensure compliance with all safety rules, procedures, batch records and work instruction through constant reinforcement of expectations… more
- Kerry (Harrisburg, PA)
- …enter batch data and monitor production workflows using SAP and physical batch records . + Verify batch integrity and troubleshoot discrepancies to ... will demonstrate strong attention to detail and expertise in batch management using SAP software. You will ensure that...to detail. + Preferred + Proficiency in SAP for batch entry and production tracking with handheld scanners and… more
- Kerry (Harrisburg, PA)
- …enter batch data and monitor production workflows using SAP and physical batch records . + Verify batch integrity and troubleshoot discrepancies to ... will demonstrate strong attention to detail and expertise in batch management using SAP software. You will ensure that...Safety Mindset + Preferred + Proficiency in SAP for batch entry and production tracking with handheld scanners and… more
- Cipla (Fall River, MA)
- …and validation documents of equipment and computer system. Preparation and qualification of e- batch record & e-Log Book. Knowledge of cleaning validation and ... records and SOPs. Knowledge of GDP. Creation and maintenance of batch record and cGMP documentation templates. Hands-on experience facilitating problem… more
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