- Cipla (Hauppauge, NY)
- …- 11:30pm Job Overview: The QA Associate ( Reviewer ) is responsible for review of batch production records , ensuring that all documentation complies ... produced according to the approved methods and specifications. Responsibilities: Review batch production records (BPRs),...field. Work Experience: Minimum 2-3 years of experience in batch record review or quality… more
- 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …revise, or draft Standard Operating Procedures (SOPs) in relation to the batch review / release process.Contribute to process improvement.Ensure turnaround times ... electronic practices.Collaborate with (cross)functional departments to resolve issues related to batch review /release, investigations, and receipt of QC test… 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. (Millsboro, DE)
- Job DescriptionThe Senior Quality Specialist ensures product/process quality system adherence and batch record review , completes quality checks and SAP ... Understanding of USDA regulatory requirements 9CFR - Required Skills: Analytical Thinking, Batch Record Review , Drug Product Manufacturing, Pharmaceutical… 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)
- …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
- Merck & Co. (Durham, NC)
- …critical site review and review of environmental monitoring data.Perform review of batch records and documentation.Perform review of ... process simulation batch records .Perform data review and run reconciliation activities as required (ie, UV and FIT testing).Perform Quality retain sample… 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
