Arunava Ghosh

Accountable for overall expansion of quality management systems, processes and procedures as per current GMP compliance for Aspen manufacturing sites. Lead site quality oversight, managed quality metrics trends alerts associated actions, exceeded in organisation operational excellence and continual improvement program. Defined global computer system validation and quality system process automation, deviation ,compliants, batch record review, failure OOS/OOT investigations, product transfer validation.

Defined and Implemented of Corporate Quality governance policies, standard operating procedure and work instructions .Monitor site Quality metrics and was accountable for regulatory Inspection intelligence analytics identifying trends of observation gap assessment and proactive compliance of Zydus manufacturing sites. Lead digital quality automation, defined data governance policies and high Quality investigation, product risk management program.

Provided strategic consultation to pharma and Biotech companies on regulatory inspection compliance and data integrity remediation, due diligence quality gap assessment and regulatory inspection response for FDA483,Warning letters and EU NOC and CEP suspension

Oversaw as Quality Management Representative govern ISO 9001 Certification of Biopharmax India. Executed global Commissioning qualification and validation of biotech (Greenfield projects of drug substance and drug product manufacturing) facilities utilities, equipment’s, upstream and downstream process equipment's as well as aseptic production filling lines, automated inspection machines. Lead facility design and validation of products including monoclonal antibodies, cellular therapeutics new ATMP programs

Lead setting up of Global CMC-Regulatory function and, Annual Report submission for the US products and Post NOC regulatory submission, drove successfully CMC submissions of all products (biologics, small molecules, API, solid dosage forms, injectables, medical devices).

Lead Quality assurance and Validation activities of site . Drive major product Technology transfer of complex generic product of Wörwag Pharma GmbH, Böblingen, Germany

Lead regulatory audit management. Drive qualification and validation projects handled cleaning validation, process validation, APQR,OOS investigation, Market quality complaints, deviations, change controls harmonization of product and process specification ,batch record review and disposition.

Lead in process QA team of recombinant vaccine manufacturing sterile fill finish facility. Reviewed master, executed batch and disposition records and assisting in batch release in SAP. Ensured aseptic manufacturing in process SQAL (Sterility Quality Assurance level). Designed Media fill, disinfectant and gowning qualification protocols and batch failure investigations, visual inspection reports.