- Cipla (Hauppauge, NY)
- …supporting manufacturing processes, with a particular focus on audit trail review , data integrity, and overall GxP compliance. Responsibilities: Perform detailed ... actions in the audit trails and escalate as needed. Review user activity logs within the batch record systems...actions are secure, traceable, and compliant with regulatory standard. Review of the batch records (manufacturing and packaging) to… more
- Cipla (Central Islip, NY)
- …finished drug products. Responsibilities include but are not limited to GMP documentation review and supporting other QA functions as needed. In this role, the ... associate II" include but are not limited to the following: Review documentation for manufacturing activities associated with commercial, development, and… more
- Cipla (Central Islip, NY)
- …/ comparison reports and any other study reports. Prepare and review laboratory investigation (OOS/OOT/Deviation) reports and ensure compliance of same. Verifying ... or other changes of any Pharmacopoeia are in effect. Review of laboratory audit trials during data review... Review of laboratory audit trials during data review against standard operating procedures (SOPs). Coordinating with the… more
- Cipla (Hauppauge, NY)
- …standards for completeness of the labels against standard operating procedures (SOPs). Review of laboratory audit trials during data review against standard ... of necessary improvements in the identified areas. Actively participating in review of data related to laboratory investigations and incidents and ensuring… more
- Cipla (Hauppauge, NY)
- …on the approved materials, once release from quality control after testing. Review and verify artwork proofs for printed packaging materials to ensure accuracy, ... and other regulatory standards for packaging materials. Ability to meticulously review artwork, packaging materials, and product documentation for accuracy and… more
- Cipla (Hauppauge, NY)
- …senior management. Maintain departmental compliance pertaining to departmental SOPs, periodic review and reporting of the environmental monitoring system. Generate, ... review , approve and maintain Validation Master Plan and summary...analyze all data, write final reports and obtain approvals. Review technical documentation such as batch records, SOPs, calibration… more
- Cipla (Central Islip, NY)
- …will be Monday to Friday Responsibilities/ Accountabilities Prepare and review Change Controls, Technical Deviations, Methods, Specifications, COAs, Batch Records, ... to provide recommendations or conclusions. Strict attention to detail and ability to review and edit content for compliance, clarity, and proper use of terminology.… more
- Cipla (Hauppauge, NY)
- …assigned and follow company policies, safety requirements, cGMP and SOP's. Review of online batch records, area/equipment logbooks, calibration/PMP records etc. ... material generated during batch process and accountability in the batch record. Review of engineering records (temperature and humidity data, calibration reports and… more
- Cipla (Hauppauge, NY)
- …assigned and follow company policies, safety requirements, cGMP and SOP's. Review of online batch records, area/equipment logbooks, calibration/PMP records etc. ... material generated during batch process and accountability in the batch record. Review of engineering records (temperature and humidity data, calibration reports and… more
- Formation Bio (New York, NY)
- …and external teams to implement corrective and preventive actions. Lead the quality review process, ensuring the effective review and approval of batch records, ... release testing, and other quality-related documentation. Foster a culture of continuous improvement and development within the quality assurance team, ensuring that all team members have the support and resources they need to succeed. Creating and… more
