Pulak Kumar Biswas Email & Phone Number

Over four years experience in pharmaceutical Validation and Qualification area. Currently i am working in Square Pharmaceuticals Ltd. as a Validation Executive.My work specialties are :• Initiate and execute validation studies throughout the facility.• prepare and write the protocols for process validation, cleaning validation, hold time study, IQ/OQ and performance qualification.• Interface extensively with the QC, Production and Maintenance departments to identify projects and problems requiring validation support.• Ensure appropriate testing and support methods validation are completed through extensive interaction with Quality Control and R&D.• Review and analyze moderately complex analytical and physical data generated from validation activities• Write validation final reports that present, summarize and offer conclusions on the validity of the process based on the results of the analysis.• Ensure accuracy and integrity of protocols, reports and documentation generated to meet regulatory authorities.• Develop and implement all necessary Standard Operating Procedures for validation of plant processes, equipment installation and operational qualification (IQ/OQ), performance qualification (PQ) and requalification of critical systems, utilities and production processes.• Work with Regulatory Affairs Department to provide validation support for regulatory submissions.• Periodic calibration and maintenance of all IPQC equipments.• Maintaining and updating the on-going validation status report for facility, system, equipments and products.

Listed skills include Cleaning Validation, Process Validation, Dossier Compilation, Regulatory Product Development, and 6 others.