- Cipla (Central Islip, NY)
- …with good documentation practices (GDP), including but not limited to: executed batch records, master batch records, product labels, and product specific ... documents Independently executes batch record review for completeness, accuracy and cGMP compliance....are met. Ability to quickly process complex information and make critical decisions with limited information required. Oversee status… more
- Cipla (Hauppauge, NY)
- …timestamped, and attributed to the correct users. Ensure that all changes to batch records are valid and consistent with the intended production process. Investigate ... escalate as needed. Review user activity logs within the batch record systems to ensure compliance with 21 CFR...of all applicants. If you require reasonable accommodation to make your application or interview experience a great one,… 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)
- …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 (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
- 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 ...their knowledge and experience but for their zeal to make a difference to the world of healthcare. The… more
- Cipla (Reid, WI)
- …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 ... the following : Works with Manufacturing/Packaging to deliver timely batch record review across all shifts. Reviews and approval...their knowledge and experience but for their zeal to make a difference to the world of healthcare. The… more
- Repligen (Clifton Park, NY)
- …Monday- Friday 2:00pm-10:30pm.**Now offering a $2500 sign on bonus for new employees!** Make a global impact-join Repligen.We're united by a mission to inspire ... silicone, plastic components, and tubing according to work instructions, batch records, and quality standards.Perform inspection of components for defects,… more
- Cipla (Fall River, MA)
- …validation documents of equipment and computer system. Preparation and qualification of e- batch record & e-Log Book. Knowledge of cleaning validation and process ... and SOPs. Knowledge of GDP. Creation and maintenance of batch record and cGMP documentation templates. Hands-on experience facilitating...their knowledge and experience but for their zeal to make a difference to the world of healthcare. The… more
- Tris Pharma (Monmouth Junction, NJ)
- …other therapeutic categories employing our proprietary science and technology.Our science and technology make us unique, but our team members set us apart; they are ... Practices (cGMPs), Food and Drug Administration (FDA) standards and batch record specifications. She/he operates and maintains various pharmaceutical packaging… 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 ... their knowledge and experience but for their zeal to make a difference to the world of healthcare. The...of all applicants. If you require reasonable accommodation to make your application or interview experience a great one,… more
- Cipla (Central Islip, NY)
- …the documents generated during the production of tablets and capsules such as Batch Manufacturing Record (BMR), PQ protocol. Perform SAP entry during and finish ... batches product. Make equipment part list required for machine, and support...and performance expectations and execution of manufacturing operations. Review batch record after finishing each step for correctness. Provide… 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 ... their knowledge and experience but for their zeal to make a difference to the world of healthcare. The...of all applicants. If you require reasonable accommodation to make your application or interview experience a great one,… 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, ensuring ... quality assurance about daily shop floor activities and any discrepancy during batch manufacturing and packing. Other duties [additional support] that management may… 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 ... professionals not just for their knowledge and experience but for their zeal to make a difference to the world of healthcare. The company believes that our biggest… more
- Cipla (Fall River, MA)
- …include but are not limited to the following : Review of batch manufacturing/packaging record. Review of engineering records such as temperature and humidity ... of all the equipment and associated controls during the batch run. Act as quality lead for all shop...their knowledge and experience but for their zeal to make a difference to the world of healthcare. The… 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
- Novo Nordisk Inc. (Boulder, CO)
- …at CMOs to manufacture clinical parenteral medicines according to approved protocols, master batch records, regulations, and timelines Lead and be an example for a ... and/or approve Standard Operating Procedures, specifications, regulatory filings, Master/Executed Batch Records, or other controlled documents as needed Responsible… more
- AUROBINDO (Durham, NC)
- …of products. Aurolife's aim is to provide healthcare at economical prices to make this a healthier world to live in.Job OverviewMust complete all proper training ... functions during IPQA absences.ResponsibilitiesCoordinate production priorities.Review IPQA entries in batch records on the floor.Assist in batch … more
