- Cipla (Hauppauge, NY)
- …and perform daily verification of balances Perform in-process checks during batch manufacturing, as per manufacturing record instructions. Collection of in-process ... weight, thickness, hardness, disintegration, friability, etc.) as per manufacturing batch record instructions. Ensure cleaning of manufacturing and equipment, area… more
- Cipla (Fall River, MA)
- …cleaning and sanitation of production area and machinery as per respective SOP during batch to batch and product to product changeover. Daily monitoring and ... materials and production lines. Conducting process checks and recording in batch manufacturing record. Controlling machine operations with minimum rejections and… more
- Cipla (Hauppauge, NY)
- …process. Dispensing printed packaging materials to packaging. Perform in-process checks during batch manufacturing and packaging, as per manufacturing & batch ... company policies, safety requirements, cGMP and SOP's. Review of online batch records, area/equipment logbooks, calibration/PMP records etc. Ensure the proper… more
- Cipla (Hauppauge, NY)
- …process. Dispensing printed packaging materials to packaging. Perform in-process checks during batch manufacturing and packaging, as per manufacturing & batch ... company policies, safety requirements, cGMP and SOP's. Review of online batch records, area/equipment logbooks, calibration/PMP records etc. Ensure the proper… more
- Cipla (Hauppauge, NY)
- …weight, thickness, hardness, disintegration, friability, etc.) as per manufacturing batch record instructions. Perform room and equipment checks (where applicable) ... Ensure the proper isolation of rejected material generated during batch process and accountability in the batch ...during batch process and accountability in the batch record. Monitor facility and product environmental operating conditions.… more
- Cipla (Hauppauge, NY)
- …weight, thickness, hardness, disintegration, friability, etc.) as per manufacturing batch record instructions. Perform room and equipment checks (where applicable) ... Ensure the proper isolation of rejected material generated during batch process and accountability in the batch ...during batch process and accountability in the batch record. Monitor facility and product environmental operating conditions.… more
- Cipla (Fall River, MA)
- …weight, thickness, hardness, disintegration, friability, etc.) as per manufacturing batch record instructions. Conduct room and equipment checks (where applicable) ... Ensure the proper isolation of rejected material generated during batch process and accountability in the batch ...during batch process and accountability in the batch record. Monitor facility and product environmental operating conditions.… more
- Cipla (Fall River, MA)
- …Specialist is responsible for the creation and revision of new and existing GMP batch production records as well as SOP's. In this role the Documentation Specialist ... not limited to the following : Works with Manufacturing/Packaging to deliver timely batch record review across all shifts. Reviews and approval of master batch… more
- Merck & Co. (Durham, NC)
- …cGMP, regulations, and our Company's Quality Management System focusing on batch record review, process/aseptic observations, critical site review, critical alarm ... Leads and Supports the Aseptic Observer Program (AOP) and Batch Record Review (BRR) workstreams for the SFQA Area....Management. Experience with Kneat, Veeva Vault, MEDS, SAP, Electronic Batch Records (MES), Trackwise and GLIMS. RCA (Root Cause… more
- AUROBINDO (Durham, NC)
- …in.Job OverviewEngineering /Manufacturing Operator is to perform all required Batch manufacturing, packing, equipment cleaning, area cleaning, in- process testing ... machinery.Perform verifications using special instruments (Caliper, Balance, etc.).Assist the Batch manufacturing, Packing & Cleaning of the equipment machinery and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …manufacturing to ensure sterility of the product/process is not compromised.Support batch review & material release in SAP for In-house reagents.Support Floor ... prior to use on the manufacturing floor.Utilize multiple electronic quality systems, batch records and SAP.Work in a team based, cross-functional environment to… more
- Cipla (Fall River, MA)
- …Control Room. Receive approved and executed documents related to SOPs, batch records, validation and qualification protocols, specifications, training records, QMS ... GDP. Issue the approved and executed documents related to SOPs, batch records, validation and qualification protocols, specifications, training records, QMS related… more
- Merck & Co. (Rahway, NJ)
- …electronic system.- Knowledge of PAS-X is preferable.GMP: Follow established inspection batch records, protocols and quality standards to ensure compliance with ... Manufacturing Practices (GMP), Laboratory Techniques, Manufacturing Quality Control, Master Batch Records, Material Selection, Pharmaceutical Process Development, Production Planning,… more
- Aequor (Athens, GA)
- …procedures accordingly to SOPs Operate the cintrificail spinning machine Batch vaccines for filling Demonstrated mechanical or electronic aptitude, cleanroom, ... required in collaboration with maintenence personnell Good documentation practices batch closing in oracle Biology/general science knowledge Mechanical diagnostics… more
- Cipla (Fall River, MA)
- …maintaining quality standard within standard norms. Cleaning machines and area as per batch to batch and product to product change over. Performing operations ... and preventative maintenance of machines. Identifying and assisting in the corrective actions of packaging related issues. Correcting status labelling at all stages of packing line with signature. Ensuring that appropriate equipment calibrations are performed,… more
- Cipla (Hauppauge, NY)
- …product impact analyses, and initiations of CAPA actions. Reviewing completed Batch manufacturing Records (BMR) and logbooks following cGMP standards in support ... of investigations. Reviewing, editing, and revising controlled documents ( batch records, logbooks, SOPs, etc.) following cGMP standards to ensure compliance with… more
- Cipla (Fall River, MA)
- …maintaining quality standard within standard norms. Cleaning machines and area as per batch to batch and product to product change over. Performing operations ... and preventative maintenance of machines. Identifying and assisting in the corrective actions of packaging related issues. Correcting status labelling at all stages of packing line with signature. Ensuring that appropriate equipment calibrations are performed,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …protocols and documentation.Provide technical quality oversight for electronic batch records.Support manufacturing and technical operations teams in trouble ... standards, industry standards, and global regulations.Provide Quality Oversight for batch records, change controls, SOPs, non-conformances, risk assessments, and… more
- Aequor (Thousand Oaks, CA)
- …The position supports commercial drug substance production and requires cleanroom oversight, batch record review, and acting as a QA liaison during manufacturing and ... use of quality systems. Duties include purposeful presence on the floor, electronic batch record review, SOP revision & approval, work order approval, and quality… more
- Cipla (Fall River, MA)
- …maintaining quality standard within standard norms. Cleaning machines and area as per batch to batch and product to product change over. Performing operations ... and preventative maintenance of machines. Identifying and assisting in the corrective actions of packaging related issues. Correcting status labelling at all stages of packing line with signature. Ensuring that appropriate equipment calibrations are performed,… more
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