PUSHKAR RANA

• Oversee quality operations activities; incoming quality control, production process control, quality engineering ensuring process validation and verification compliance, review of deviations/ investigation and escalation of quality issues to address the root cause and implement corrective and preventative actions
• Collaborate with the operations team to identify process improvement opportunities
• Responsible for conducting GMP trainings to train the QC, QA and other department based on the organizational training program
• Coordination with the HO and R&D centre for the new product introduction and transfer of technology to the unit for commercial manufacturing
• Skilled at working independently and collaboratively in a team environment.
• Sampling, testing and release of all the raw materials, packaging material, in process, finish product and stability testing
• Complaints, OOS/OOT, deviations and non-conformances resolution.

• Manufacturer of Oral solid dosage, oral liquid, external preparations and sachets.
• Ensure that the procedures and specifications of vendors under contract are also appropriate and followed, i.e., maintain control and take responsibility for external services providers (contract manufacturers, contract laboratories, etc.).
• Ensure that appropriate manufacturing in-process controls are implemented and are followed during manufacturing operations and results are satisfactory.
• Approve or reject drug products manufactured, processed, packed, or held under contract by another company, i.e., final product release is not delegated to a contractor.
• Validation of HVAC, water system and compressed air. Review and approval of site master file, validation master plan and other QMS document.

• Product Handled: Tablets, Liquid Oral, Dry Syrup, Ointment, sterile, dry powder injection and Oral Hygiene
• Responsible for the development/ implementation of the quality strategy plan in compliance with CGMP and CFR requirements at third party manufacturer
• Managed 21 CMO sites for data integrity and CFR part 11 compliance.
• Quality oversight of 5 CDMO sites of incoming quality control, manufacturing quality assurance, analytical & microbiology laboratories, quality engineering (statistical quality control), and document control departments.
• To ensure that manufacturing unit documents and procedures are in line with the latest regulatory requirement.
• To assess the feasibility of new product and to perform the technology transfer of new product at third party manufacturing sites.
• To assess the feasibility of new product and to perform technology transfer of new product at third party manufacturing sites.

• To prepare and review analytical documents, standard operating procedure, user requirement specification
• Review and investigation of laboratory incidents and change control
• Analysis of Finish product, RM/PM and stability samples as per respective SOP
• Review of QC records, reports of finish product, water analysis and Calibration records of instruments in QC lab
• Planning, analysis, approval or rejection of all the packing material received at site
• To conduct training Good Laboratory Practices in the Lab
• Preparation of QC internal and external calibration schedule and to ensure that the calibrations are performed as per the approved schedule.

• Analysis of in-process, finished product and stability product and packing material samples
• Analysis of cleaning and process validation samples
• Planning and analysis of packaging materials
• Calibration of instruments asper written schedule
• Preparation and standardization of volumetric solution
• Data recording and review of stability chambers
• Data entry in SAP.

Sampling and testing of raw materials, finish products and packaging material samples.

Preparation of testing reports and certificates of analysis.

Recording and release of material in ERP software.

Calibration of QC instruments.

• Sampling and analysis of raw material finish product, stability and packaging material samples.