Thulasingam R

• Leading team of USFDA Plant compliance, audits, Investigation and CAPA management, Manufacturing IPQA, Analytical quality assurance, Product surveillance (Market complaints, Adverse drug events, Field Alert and product recall) consists of about 30 members in view of enhancing the quality.
• Aseptic process monitoring, Contamination control strategy, quality improvement projects, Computer System Validation (CSV) review, Stability management and day to day operation of drug product (Sterile) manufacturing facility.
• Multiple USFDA inspections handled

Team Lead for the following activities in Steriles Manufacturing facility for USFDA:

• Investigations/CAPA/ QMS/ handling in Track Wise associated with job responsibilities
• Aseptic processing monitoring
• Shop floor lead for IPQA
• Finished product, Raw materials, packing materials, miscellaneous materials review and release

Responsible for handling quality aspects related to New product launches from External Manufacturing Sites (EMQA).

• Audit Management
• Audit of external manufacturing sites of Dr. Reddy’s
• Batch Manufacturing Records (BMR), Process Validation, Hold Time Protocols & Reports
• Change controls related to products, process, equipment and documentation
• Investigations review
• Quality Agreements review
• Responsible for monitoring of “Validation” batches at site as part of validation team.

• Handling of Market complaints/ recalls
• Internal and External Audits
• Performing internal audits for plants/ CFAs & other CFT as required.
• Change Control Management & CAPA
• Import product release
• Contract Manufacturing QMS review

• Handling of Market complaints/ Product Recall, Change / Deviation Management, Process Validation, Annual Product Quality review (APQR), Finsihed product review and release.
• Executing the Technology transfer from one manufacturing location to another manufacturing location with facility suitability evaluation audits, adequate master document issuance, validation execution, etc.
• Review of Quality agreements with business partners for adequacy/ updation.

• In process quality assurance chemist for tablet, oral liquid and ointment manufacturing activities. Supported sampling, Line clearance, in process checks and batch record review activities.