- Legend Biotech USA, Inc. (Raritan, NJ)
- … records , labels, forms, etc. are printed and available for productionOversee batch records review and completeness of all associated documentation ... the treatment of multiple myeloma.Legend Biotech is seeking a Batch Record & Document Coordinator as part...as required for batch releasePerform First Quality review for executed batch records … more
- Cipla (Central Islip, NY)
- … records , product labels, and product specific documents Independently executes batch record review for completeness, accuracy and cGMP compliance. ... metrics for Batch Review and Release Contributes to process improvement of batch records and associated processes (eg turnaround times) to ensure all QA … more
- Cipla (Hauppauge, NY)
- …with cross-functional teams (eg, IT, production,) to identify opportunities for improving the batch record review process, particularly in relation to audit ... needed. Review user activity logs within the batch record systems to ensure compliance with...actions are secure, traceable, and compliant with regulatory standard. Review of the batch records … more
- Merck & Co. (Durham, NC)
- …of operations on the production floor, coordination across processing suites, real-time batch record review , execution of aseptic processing requirements ... and reports issues with product accountability and SAP system discrepancies. - Executes real-time batch record review and ensures timely closure of shopfloor… 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
- 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 (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
- Cipla (Fall River, MA)
- …batch record . Monitor facility and product environmental operating conditions. Review of engineering records such as temperature and humidity data ... (eg, weight, thickness, hardness, disintegration, friability, etc.) as per manufacturing batch record instructions. Conduct room and equipment checks (where… more
- Cipla (Reid, WI)
- …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
- 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
- Merck & Co. (Rahway, NJ)
- …manufacturing for clinical supplies.- Duties include compliance oversite of program-related activities, batch record review and approval, deviation and/or ... independently perform or coordinate routine and specialized audits of batch documentation, data, information, procedures, equipment and systems, and/or facilities… 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 ... materials for subject matter input. Track and manage periodic review . Develop strategies and documents for cleaning and process...and SOPs. Knowledge of GDP. Creation and maintenance of batch record and cGMP documentation templates. Hands-on… more
- Cipla (Fall River, MA)
- …not limited to the following : Review of batch manufacturing/packaging record . Review of engineering records such as temperature and humidity data ... calibration and PM records , pest control records and contractor related functions. Review and...of all the equipment and associated controls during the batch run. Act as quality lead for all shop… more
- Formation Bio (New York, NY)
- …and preventive actions. Lead the quality review process, ensuring the effective review and approval of batch records , release testing, and other ... implementation, and upkeep of quality systems and procedures, including SOPs, batch records , and quality metrics.standard operating procedures (SOPs) pertaining… more
- Aequor (West Greenwich, RI)
- …of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) to efficiently review batch records , logbooks, and on-the-floor QA processes. ... directly with Manufacturing staff during bulk drug substance operations to facilitate batch record and attachment reviews, logbook reviews, area changeover… more
- Tris Pharma (Monmouth Junction, NJ)
- …Manufacturing Practices (cGMPs), Food and Drug Administration (FDA) standards and batch record specifications. She/he operates and maintains various ... packaging of pharmaceutical products according to SOPs, cGMPs, FDA standards and batch record specifications Performs the day-to-day activities of the packaging… more
- Cipla (Fall River, MA)
- …job duties for this position include but are not limited to the following: Review of batch manufacturing/packaging records . Release of raw materials, ... packaging materials and finished products through approval of respective COA. Review of engineering records such as temperature and humidity data calibrations,… more
- Cipla (Hauppauge, NY)
- …or mix-ups . To dispense the printed packaging materials as per the batch packaging records . Conduct regular inspections of incoming and outgoing goods, ... on the approved materials, once release from quality control after testing. Review and verify artwork proofs for printed packaging materials to ensure accuracy,… 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
