SARANG DAITHANKAR
Hyderabad,TG
Summary
Driven Assistant Manager with deep expertise in OSD production, pharmaceutical QMS, operations, and compliance. Skilled in leading teams to achieve cGMP, optimize processes, and deliver top-quality products. Proven success navigating audits from Canada, USFDA, MHRA, TGA, ROW, Health and WHO. Seeks challenging role to leverage expertise and drive meaningful impact.
Overview
13
13
years of professional experience
Work History
Assistant Manager - OSD Production QMS
Aurobindo Pharma Ltd
12.2019 - Current
- Oversee daily operations on the shop floor to ensure compliance with regulatory standards and company protocols
- Drive Change Management initiatives by proactively initiating Change Control processes aligned with production schedules, facilitating facility modifications, and overseeing the revision of Standard Operating Procedures (SOPs) and documents
- Conduct thorough investigations into process and material non-conformances reported during manufacturing processes, ensuring prompt resolution and corrective actions to maintain product quality and regulatory compliance
- Lead investigations and responses to market complaints, product recalls, and inquiries from contract manufacturers, focusing on Change Control, Batch Record execution, and Corrective and Preventive Actions (CAPAs) implementation
- Initiate and execute CAPAs, overseeing action item implementation within designated timelines, and conducting effectiveness checks to continuously improve processes and address quality issues
- Develop protocols for hypothesis and evaluation studies to support continuous improvement initiatives and optimize manufacturing processes
- Prepare User Requirement Specifications (URS)
- Conduct Phase II investigations into Out-of-Specification (OOS) and Out-of-Trend (OOT) results reported at the site, implementing corrective measures to maintain product integrity and compliance
- Implement Quality Risk Management practices to identify, assess, and mitigate risks throughout the product lifecycle, ensuring patient safety and regulatory compliance
- Manage projects involving new equipment installation qualification, new product launches, and end-to-end validation processes, ensuring successful implementation and compliance with regulatory requirements and industry best practices
- Serve as both an auditor and auditee in internal audits, conducting thorough assessments of quality systems, processes, and procedures to identify areas for improvement and ensure compliance with regulatory standards
- Collaborate with Corporate Quality Assurance during audits, providing support as an auditee to facilitate a comprehensive review of quality practices and adherence to regulatory requirements.
Sr. Executive (Team Leader Role OSD Production)
Strides Emerging Markets Ltd (Strides Shasun)
05.2017 - 12.2019
- Responsible for Entire manufacturing block for manufacturing and compliance.
- Worked in the role of the Team leader responsible for all production activities.
- Planning of manufacturing batches and required for the execution of plan.
- Training and evaluation of the production Technician and student trainee for their qualification to specific task or to operate specific equipment
- Preparation and revision of standard operating procedures, documents of production batch documents
- Raising requisition for the requirements of consumables through SAP
- To co-ordinate for calibration/preventive maintenance for all production equipment and instruments.
- To co-ordinate with all other departments to meet the production targets
- Investigation in case of any process deviation, non- compliance, and providing CAPA
- Implementation of quality management system as per cGMP and international requirements at all levels of manufacturing
- Review of all the Executed manufacturing documents and post the respective goods movements into SAP
- Responsible for initiation, impact analysis and closing of change control within time frame.
- Responsible for investigation and root cause analysis of Market Complaint.
- Preparation of second phase investigation for OOS and OOT.
- Responsible for risk evaluation and implementation of actions identified during risk assessment.
- Responsible for initiation, implementation, closing and tracking of CAPA.
- Responsible for all QMS and compliance related activities.
- Responsible for preparation and execution of URS, DQ, TM, IQ and OQ of process equipment.
- Responsible for user support in problem and deviation management through the Trackwise.
Pharmacist
Apotex Research Private Ltd
06.2015 - 04.2017
- To be self-disciplined & maintain same in the production department.
- To maintain the safety and housekeeping practices at work place.
- To maintain the online documentation related to production activities.
- To follow the production process as per defined procedure
- To plan the production activities in the areas as per the schedule on daily basis & deliver the same to down level for its execution
- To allocate the job responsibilities for technicians in production area.
- To impart training as per job requirement in the area.
- To make necessary SAP entries related to batch document as per procedure.
- To check the preventive maintenance status of the required equipment as per schedule and get it done.
- Calibration and Qualification of Equipment/instruments on shop floor.
Senior Technical Officer
Dr. Reddys Laboratories Ltd
02.2012 - 06.2015
- Planning of manufacturing and Manpower.
- Compliance to laid standards of the good manufacturing practices.
- Carrying installation and qualification of production equipment.
- Compliance to specification and validation methods.
- Training and evaluation of the Technician.
- Preparation and revision of standard operating procedures, documents of production batch documents.
- Raising requisition for the requirements of consumables through SAP.
- To co- ordinate for calibration/preventive maintenance for all production equipment and instruments.
- To co-ordinate with all other department to meet the production targets.
- Investigation in case of any process deviation, non- compliance.
- Responsible for initiation, implementation and tracking of CAPA.
- Implementation of quality management system as per cGMP and international requirements at all levels of manufacturing.
- Review of all the Executed manufacturing documents and posting the respective goods movements into SAP.
Trainee
Mylan Laboratories Ltd
11.2010 - 02.2012
- Worked as Trainee in Production Department.
Education
Skills
- Track wise, Metric Stream
- SAP, ERP, LIMS
- Process pad (Minitab equivalent)
- MS Office
- Change Management
- Deviation Management
- CAPA Management
- OOS/OOT investigation
- Audit & Compliance
- Risk Management
- Equipment Qualification
- Project Management
- Document Management
- Training Management
- Process Evaluation
- CQA/CPP Trend Review
- Equipment Qualification
- Process Validation/CPVM
- Cleaning Validation
Accomplishments
- Awarded with Talent of the Month award at Aurobindo Pharma.
- All the equipment in OSD manufacturing area upgraded to 21 CFR Compliant (210, 211 and part 11)
Industrial Skills
- Change management
- Deviation management
- CAPA management
- OOS/OOT investigation
- Audit & Compliance
- Market Complaint investigation, FAR cases handling.
- GxP Implementation
- Risk Management
- Equipment Qualification
- Project Management
- Document management
- Training Management
- Process Evaluation
- CQA/CPP trend review
- Process validation/CPVM
- Cleaning validation
- Tablet/Capsule Manufacturing/Troubleshooting
Machines Handled
- Pharmaceutical manufacturing equipment's supplied by Ganson, Alliance and Bectochem.
- GEA inline Granulation equipment
- Glatt Auto coater (86 Inch), Ganson coating machine (36/66 inch)
- Compression (Fette, Sejong, Korsch, GEA)
- Capsule filling machine make PAM AF-90T, AF-150T.
Audit Faced
- USFDA
- MHRA
- Health Canada
- TGA
- WHO
- ROW
Timeline
Assistant Manager - OSD Production QMS
Aurobindo Pharma Ltd
12.2019 - Current
Sr. Executive (Team Leader Role OSD Production)
Strides Emerging Markets Ltd (Strides Shasun)
05.2017 - 12.2019
Pharmacist
Apotex Research Private Ltd
06.2015 - 04.2017
Senior Technical Officer
Dr. Reddys Laboratories Ltd
02.2012 - 06.2015
Trainee
Mylan Laboratories Ltd
11.2010 - 02.2012
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