Avinash Jaiswal Email & Phone Number

Mumbai, Maharashtra, India

Ambernath Mumbai

To be responsible for initiation and set up of complete formulation R&D at Enaltec Labs.• To be responsible for implementation of quality system in the entire cross functional departments of Formulation R&D of Enaltec Labs.• To be responsible for evaluation and qualification of vendors (RM, PM)• To be responsible for review and approval of all quality documents.• To ensure release / reject the raw materials, packing materials, intermediates and drug products as per procedure• Plan, schedule, conduct, report and close audit activities of contract manufacturing units to assess compliance with applicable regulations/guidelines cGMP, ICH, WHO, client requirements, SOPs and project specific guidelines/instructions.• To be responsible for review and handling of quality agreement with vendors, CMOs, clients and external labs.• To be responsible for review, evaluate and approval of deviations, change control, OOS and OOT.• Initiating, implementing, and controlling product quality aligning with current pharmacopeias and fulfilling all the documentations• Handling regulatory audits (USFDA, WHO AND DCGI)• Handling audits for contract labs, third parties and external labs.

Mumbai

• Monitoring the study operation • Recommend measures to ensure GLP compliances.• To review of validation protocol and report.• Handling of SOP training to the new and existing staff.• Audit and compliance of facility as per regulatory requirement and in house SOP.• Communication with regulatory and CQA department for regulatory submission• Prepartion and review of quality system SOPs.• Schedule and conduct in process audit.• Resolving queries and compliance as per regulatory requirement and In house SOPs.• Schedule and conduct vendor audit• Review and compliance of Protocols and Standard test procedure• Review and compliance of calibration of instruments (HPLC, UPLC, LCMS etc)• To maintain all the controlled documents and their records issued for MV• Review of technology transfer data• Maintenance of different logs (Deviation, Change Control) and documents.• Handling of OOS and OOT• Review and tracking of the product related deviations and change controls.• Review of Stability study data of product batches manufactured.