PANKAJ SWAIN

Reading of all GMP data of laboratory in compliance for laboratory readiness for audits. Management of microbiology lab in terms of requisites, deliverables and qualification status. Participate in inspections conducted by regulatory agencies like USFDA, Health Canada and got appreciated by inspectors, got passed providing compliance within deadline. Ensure timely planning, successful media fill validation, equipment qualification, product AMV & In-house validation studies. Handling of QMS documents- Change control, CAPA, Incidence, Deviations & Investigation. Provide support for all Media fill, Sterility failure investigations, EM excursions at site, with identification of root cause and effective CAPA. Performs special projects and other duties as assigned. Streamlined workflows by identifying bottlenecks in existing systems and implementing appropriate solutions.

Supervision and training and development of QC microbiology staff and provide guidance on best aseptic practices. Communication with manufacturing facilities, and external department staff on microbiological and environmental operational issues. Serve as reviewer of facility, equipment and product test data and reports. Successfully faced and headed the department during MHRA, USFDA Inspection and customer audits like Cipla, Abott. Cross-trained existing employees to maximize team agility and performance.

General administration and planning of activities of Microbiology department. Preparation of protocols & execution of Validation of equipments Autoclave, LAF, Incubators & DPB. Document preparation, implementation and maintenance of SOPs, AMV, study protocols and reports in Microbiology department.

Review of BET test by Gel-clot method, validation and calibration of Autoclave, LAF, DPB. Implementation and sustaining concept of right first time. reduction in OOS & OOT, improvement in sample per analyst; driving improvement projects including bottlenecks identification and resolution, procedure vs practice gaps, simplification of SOPs and alike. Provide support for all EM excursions at site, with identification of root cause and effective CAPA. Successfully faced and passed inspections of EU-GMP, Azerbaijan, Zydus with giving compliance reports within deadline. Improved customer satisfaction by addressing and resolving complaints promptly.

Reviewing of all Sterility test results, Media preparation records, Autoclave qualification, Water tests, BET & daily records. Responsible for SOP, Protocol preparation & revision and execution. Training all staff members on cGMP, ALCOA, BET, Media fill. Participated in audits by ROW countries.

General administration and planning of activities of Microbiology department. Preparation implementation and maintenance of SOP, Protocols and reports in Microbiology department. Faced internal CQA audits, WHO, IDMA, ISO. Handled the greenfield project to set up of new laboratory, hand-on experience of conducting review of Media Fill (DPI & Eye Drops).

Performed Environment monitoring in Aseptic sterile facility, Sampling and Water analysis of WFI, Purified water, PSG samples, Double door Autoclave operation, handled microbial cultures, carried out antimicrobial effectiveness test for oral liquids, ointments, Sterility tests of Dry powder injection vials.