Active participation in the internal remediation of one of the top global pharma MNCs based at Nashik, India (in the retrospective review of laboratory errors like OOS, OOT and laboratory incidents).
Active participation in handling Import alert set by USFDA for an API manufacturing company in its Nashik Manufacturing facility. Significant Contribution in data integrity review, OOS / OOT / Incidents review, SOPs Gap analysis and revision, Quality Risk Assessment, Analytical data review of release & stability during remediation. Prepared the review reports and summaries for the data integrity assessment and the same were submitted to USFDA
Performed an assignment of finalising QC layouts for a reputed Pharma MNC at its Vietnam manufacturing site.
Involvement in remediation during import alert by USFDA at a formulations manufacturing company in its Aurangabad Manufacturing facility. Significant Contribution in data integrity review, OOS / OOT / Incidents review. Prepared the review reports and summaries for the retrospective review assessments performed during remediation.
Conducted number of Training sessions on the topics like handling OOS / OOT / Incident investigations, Good Laboratory Practices, Good Manufacturing Practices, Good documentation practices, Stability study management, Deviations, Compliance, GMP and Change control management at few reputed manufacturing company sites and Training institutes based in Mumbai, Pune, Aurangabad, Nashik, Baroda, Bangalore, Baddi,
Provided technical consultancy and training services to 20-25 reputed pharmaceutical companies / Institutions / Consultancy groups.
Closure of more than 1000 positions for about 25 reputed pharmaceutical companies and CROs in since starting our operations (in 8 years till July May 2023), covering positions from analyst level up to Vice President Level.
Conducted gap analysis in QMS systems and records at API & formulation unit in Vadodara. Conducted training on “Handling of Deviation.”
Conducted gap analysis in an USFDA/EU approved Indian API company based in Tarapur in QC departments (including chemical, instrumentation and microbiology departments) from data integrity and GMP/GLP compliance perspective for all QC systems.
Provided technical consultancy and support in the successful EU audit at an Indian API company based in Dehradun conducted in April 2023. The support was provided in the review of QMS documents and QC laboratory records, including OOS, deviations, change controls, complaints, etc.
Provided training support in the successful USFDA audit at an Indian API company based in Bangalore conducted in April 2023. The support was provided in the training of QC / QA staff, including topics such as OOS, Contamination control in QC and human error reduction.
Training conducted at an Indian pharma company based in Bangalore (API and formulation units) on the topics, “Qualification of GMP Trainer” and “Pharmaceutical QMS, covering OOS, Deviations, Change management, CAPA and Market complaints.”
Training conducted at an Indian Medical device and IVD manufacturing company based in Thane - Mumbai on the topic, “Good manufacturing practices”.