Ritwik Thakura, Phd Email & Phone Number

India

Visakhapatnam, Andhra Pradesh, India

Qualification / Validation for Drug Substance & Drug Products

Chennai Area, India

Validation & Qualification of Solid Oral Formulations.

Hyderabad Area, India

• Conducting audits of Facility, Equipment & Utilities on periodic basis and to ensure that all action plans are completed within the specified time line.• Review and Approval of qualification protocol of Equipment / Facility.• Review and approval of Calibration schedule for equipments and instruments.• Review and approval of PMPs for adequacy and ensure implementation as per schedule.• Review and approval of design qualification and ensure that the design qualification of new… Show more • Conducting audits of Facility, Equipment & Utilities on periodic basis and to ensure that all action plans are completed within the specified time line.• Review and Approval of qualification protocol of Equipment / Facility.• Review and approval of Calibration schedule for equipments and instruments.• Review and approval of PMPs for adequacy and ensure implementation as per schedule.• Review and approval of design qualification and ensure that the design qualification of new facility / equipment meets the requirement for intended function.• Review and approval of SOPs /OIs / URS /MMRs / MKTs for adequacy.• Review and approval of cleaning validation documents for its adequacy.• Ensure that routine area monitoring is carried out as per schedule.• Monitoring of CAPA arising from audit and incident.• Investigate into incidents and ensure action plan are implemented and closure of the same.• Approval and verification of change controls related to facility / equipment / utility / standard procedure.• Review and updating of OSHAS, EMS documents.• Co- ordination of self inspection audit and cGMP audits.• To review and updation of the Technical Agreements & Quality Risk Assessment. Show less

VALIDATION ACTIVITIES IN NEW PROJECTS :(At Aurobindo Pharma Ltd.) EQUIPMENT QUALIFICATION- Preparation & Review of qualification protocol (URS/FAT/DQ/SAT/IQ/OQ/PQ) of various process equipments.- Participation in Facility Validation activities in new projects.- Execution of all equipment qualification activities in projects.- Coordination with vendors & engineering dept. regarding new project.- Verification of all type of vendor documents required for… Show more VALIDATION ACTIVITIES IN NEW PROJECTS :(At Aurobindo Pharma Ltd.) EQUIPMENT QUALIFICATION- Preparation & Review of qualification protocol (URS/FAT/DQ/SAT/IQ/OQ/PQ) of various process equipments.- Participation in Facility Validation activities in new projects.- Execution of all equipment qualification activities in projects.- Coordination with vendors & engineering dept. regarding new project.- Verification of all type of vendor documents required for qualification.- Core member of FAT (Factory Acceptance Criteria) committee.- Verification of calibration activities of new equipments & instruments.- Impact Assessment, Risk Management & Evaluation for proposed changes and deviations regarding Equipment Qualification activity. PROCESS VALIDATION- Preparation of protocols for Exhibit & Validation Batches.- Sampling from various step as per process validation/ Exhibit protocol.- Preparation of reports for Exhibit & Validation Batches.- Impact Assessment, Risk Management & Evaluation for proposed changes and deviations regarding Process Validation activities. WATER SYSTEM VALIDATION- Preparation& review of water system validation protocols (URS/DQ/FAT/IQ/OQ/PQ) in new projects.- Preparation& review of water system validation reports.- Execution of Water System Validation activities.- Impact Assessment, Risk Management & Evaluation for proposed changes and deviations regardingWater System activity. HVAC VALIDATION- Preparation & review of HVAC validation protocol (URS/DQ/FAT/IQ/OQ/PQ) in new projects.- Execution of HVAC validation activities of different class area.- Impact Assessment, Risk Management & Evaluation for proposed changes and deviations regarding HVAC activities. Show less

Baddi & Sikkim

Previous Job Responsibilities: (At Torrent Pharmaceuticals Ltd.)• Validation Activities: CLEANING VALIDATION- Preparation of cleaning validation protocol & report.- Preparation & Execution of cleaning validation routine verification protocol & report.- Preparation & Execution of Clean and Dirty Equipment Hold Time Study protocol and report.- Impact Assessment, Risk Management & Evaluation for proposed changes and deviations regarding Cleaning Validation activities.… Show more Previous Job Responsibilities: (At Torrent Pharmaceuticals Ltd.)• Validation Activities: CLEANING VALIDATION- Preparation of cleaning validation protocol & report.- Preparation & Execution of cleaning validation routine verification protocol & report.- Preparation & Execution of Clean and Dirty Equipment Hold Time Study protocol and report.- Impact Assessment, Risk Management & Evaluation for proposed changes and deviations regarding Cleaning Validation activities. PROCESS VALIDATION- Preparation of protocols for Optimization & Validation Batches.- Sampling from various step as per process validation/optimization protocol.- Preparation of reports for Optimization & Validation Batches.- Participation in Technology Transfer activity of new products.- Impact Assessment, Risk Management & Evaluation for proposed changes and deviations regarding Process Validation activities. TECHNOLOGY TRANSFER ACTIVITY- Take part in Technology Transfer of products from site to site - Take part in Technology Transfer of products from FND to site  HVAC VALIDATION- Preparation & Execution of HVAC validation protocol.- Preparation & Execution of Periodic Monitoring Reports of different class area.- Impact Assessment, Risk Management & Evaluation for proposed changes and deviations regarding HVAC activities EQUIPMENT QUALIFICATION- Preparation of qualification protocol (URS/FRS/DQ/IQ/OQ/PQ) of various process equipments.- Preparation & Execution of Periodic Monitoring Reports of equipments of its state of validation.- Impact Assessment, Risk Management & Evaluation for proposed changes and deviations regarding Equipment Qualification activity. WATER SYSTEM VALIDATION- Preparation & Execution of water system validation activities.- Preparation of annual water quality review report.- Impact Assessment, Risk Management & Evaluation for proposed changes and deviations regardingWater System activity. HOLD TIME STUDY Show less

Research Doctorate, Pharmaceutical Sciences & Chemical Engineering

Pharmaceutical Waste water treatment

Master Of Pharmacy, Pharmaceutics And Drug Design, A+

Master'S Degree, Pharmaceutics And Drug Design, Distinctions

Activities and Societies: Member of Red Cross Working in validation activities of Pharmaceuticals Industries(Process Validation,Equipment.

B. Pharma, Science