QA Group Lead - A & Z Pharmaceutical - Hauppauge, NY
(2016-07)
- Perform batch record review and record maintenance to support product release.
- Review & release MMR & BPR, prepare deviation & OOS.
QA Inspector - Innovative Labs, LLC - Hauppauge, NY
(2014-03 - 2016-07)
- Perform batch record review and record maintenance to support product release.
- Experience in FT-IR/NIR software programs and wet chemistry testing
- Perform visual inspection on filling/packaging lines during inspection & document all inspections/observations on corresponding batch folder paperwork.
QA Supervisor & Internal Auditor - Kabco Pharmaceuticals - Amityville, NY
(2006-08 - 2013-04)
- Perform batch record review and record maintenance to support product release, in process release stability program and raw material release. These include review of data sheets, reports, logbooks, laboratory notebooks, check & review manufacturing directions, check & release packaging components, packaging line clearance and performing release functions according to FDA guidelines also responsible for OOS/MIR. WareHouse, Packaging materials, Batch record and also in house and outdoor auditing p
- Perform visual inspection on filling/packaging lines during inspection & document all inspections/observations on corresponding batch folder paperwork.
- Perform all tasks including testing and documentation in a high quality and timely manner following cGMP. Perform all tasks effectively in a team environment.
- Responsible for handling customer's complaints.
- Follows all laboratory safety and housekeeping procedures.
- Ensures all of the appropriate training has been completed and documented. This includes procedural training, safety and cGMP training.
- Activity involved in initiatives for continuous improvement.
QA Inspector - Square Pharmaceuticals - BANGLADESH
(2000-08 - 2003-02)
- Planning, organizing work schedule, data review and release, test reports and more advanced analytical testing to support the operation.
- Perform work schedule to ensure testing and other activities performed in a high quality efficient and timely manner.
- Perform data analysis and trending and provides summary reports.
- Participates in internal and external audits.
- Provide product COA release for Raw Material, In-process, Final Product and Stability.
- Performs responsibilities associated with departmental hiring and training of personnel.
