Taking care of all QA activities

• Ensuring adherence of workmen and process to the implemented cGMP principles in shop floor activities.• Handling of QMS documents (Change Control, Deviation, Incident, market complaint, Return Goods, Recall, CAPA, and Investigation).• Handling of Regular QA activities documentation and manufacturing.• Handling all department sops’s and related documents preparation, review and implementation. • Handling of annual training program and training report.• Implement guideline or training for executive, officers in routine production activities quality circle meeting and safety meeting.• Handling qualification and validation.• Review of production, Quality control, maintenance, stores, human resource and other department’s sops, analytical reports, cGMP documents and protocols.• Handling of internal audit and external audit.• Handling of audit report and follow up.• Ensure audit compliance and CAPA follow up & implementation.• Handling of dispatch activities and its related documentation.• Handling of Artwork.• Handling of New Product Permission.• Handling of Drug License and FSSAI requirements.

• Ensuring adherence of workmen and process to the implemented cGMP principles in shop floor activities.• Handling of market complaint. • Handling of QMS documents (Change Control, Deviation, Incident, Return Goods, Recall, CAPA, and Investigation).• Handling of document control. • Handling Of Regular QA activities.• Preparation, Review, Training and Implementation of QA SOP’s and documents. • Review, Training and Implementation of other department sop’s and documents. • Ensure annual training program and training report.• Implement guideline or training for executive, officers in routine production activities quality circle meeting and safety meeting.• Preparation, compilation, review of protocols and process related documents and monitoring the execution of the same.• Preparation and review BMR & BPR with the consulting of production head and QA head.• Coordinate with other departs of production, Quality control, maintenance, stores, Human resource & admin for sop preparation, department formats and records.• Review of production, Quality control, maintenance, stores human resource and other departments sops, cGMP documents and protocols.• Review of analytical documents and records.• Handling of internal audit and external audit.• Preparation of audit report and follow up.• Ensure audit compliance and CAPA follow up & implementation.• Handling of dispatch activities and its related documentation.• Handling of annual calendar training schedule.

Executive Officer. Oct.2012 to Aug.2014 (1year 11months) • To monitor that approved procedures are followed during dispensing and online processing at the end packing.• Monitoring of dispensing, online process manufacturing.• [Tablets/Capsules/Oral Liquids/Ointments/Dry powders]• Routine Inprocess quality Assurance activities and ensuring cGMP and SOP compliance.• Handling of system Application and Product development (SAP).• Issue of BMR, BPR and related documents for routine activites.• Review of BMR,BPRs and sharing respective documents to customers.• Monitoring the Repacking & Disposal of Returned goods.• Monitoring Calibration of Instruments and Equipments.• Involved in Annual Product Quality Reviews.• Dispatch of finished goods and handling of Data Loggers with summarizes data’s.• Handling of IPQA chemist and activities.• Handling of customer in product requirements.• Involved in market complaint investigation report.

• To monitor that approved procedures are followed during dispensing and online processing at the end packing.• Monitoring of dispensing, online process manufacturing.• [Tablets/Capsules/Oral Liquids/Ointments]• Routine Inprocess quality Assurance activities and ensuring cGMP and SOP compliance.• Handling of system Application and Product development (SAP).• Issue of BMR, BPR and related documents for routine activites.• Review of BMR,BPRs and sharing respective documents to customers.• Monitoring the Repacking & Disposal of Returned goods.• Monitoring Calibration of Instruments and Equipments.• Execution of process Validation Protocol, Process Validation Report and Validation of HVAC system.• Sampling of all inprocess sample, control samples, validation samples, stability samples, cleaning validation samples, HTS samples.• Execution of Cleaning validation protocol and report.• Involved in Annual Product Quality Reviews.• Dispatch of finished goods and handling of Data Loggers with summarizes data’s.

• To monitor that approved procedures are followed during dispensing and online processing at the end packing.• Monitoring of dispensing, online process manufacturing.• [Tablets/ Capsules/Ointments/Oral Liquids]• Monitoring line clearance. • To maintain all In-process Records as per SOPs• Monitoring Environmental conditions. • Monitoring and Maintain In-process sample control sample and out sourcing control samples.• Monitoring the repacking & Disposal of returned goods.• Monitoring Calibration of Instruments and Equipments• Involved in preparation of process validation, cleaning validation protocols.• Monitoring of all the in process activities as per cGMP requirements.• Extensive training to the employees on cGMP, ISO. Validation and its evaluation.• Impart training to all employees on personnel hygiene, change room practices general housekeeping, pest and rodent control and its importance.• Maintains the following SOP’S.• In-process monitoring procedures.• In-Process Records and Calibration.