A Quality oriented professional with over 21 years of experience in Quality Assurance, Quality Control, Quality engineering, Quality auditor, pharmaceutical regulations and regulatory audit compliance.
The area of expertise is as per the requirement of USFDA, EUGMP, PICS, MHRA, TGA, TPD, ANVISA, WHO & Schedule-M Guidelines.
The key competencies include, Quality Compliance, Supplier Audit, build systems to encourage compliance with the principles of data integrity, computer system validation, Training, Risk assessment, Facing the audits, preparation and review of audit compliance, Qualification & validation, system development for CAPA effectiveness, stability studies & solving preapproval or post approval queries raised by regulatory agencies etc. · Independently handled - Quality assurance and Quality Control department for more than 13 years.
· Audits faced- USFDA (7 times), ANVISA, MHRA, MCC, TGA,IDMA excellence, WHO audit, EU regulatory (8 times) , Yemen MOH, Digemid (Peru), Russian Authority audit etc.
· Analytical Background: The analytical background includes, physical, chemical, microbiological testing of raw material, finished product & Stability samples. Handled the chromatographic instruments – HPLC, GC, IR, UV Visible spectrophotometer, AAS etc.
· Technical support-
o cGMP and data integrity gap audit.
o Support in facing regulatory audits & compliance report review
o Support in product development and/or regulatory submission or evaluation of readymade dossiers which can be used after site transfer for commercial manufacturing.
· Expertise in GXP Computerised systems-
o Major Software handled - Lab solution software, Empower 3 software, LIMS, TRIMS & Track wise
o Provide technical support to process owner during Computer system validation, Review of Computerised system validation documents for compliance, auditing the computer system supplier, performing GAP audit of Computerised systems, Evaluation of Computerised systems with respect to cGXP compliance , data integrity controls and ease of operating pragmatic approach
· During tenure audited more than 500 vendors/suppliers and trained more than 5000 candidates. I am approved Auditor by the multinationals I worked and also I am CQI-IRCA Certified QMS/Lead Auditor as per ISO9001:2015).