Vaibhav Jain

• Managing overall Laboratory Quality Assurance activities of entire Matoda site (4 Quality Control laboratories) with team of 67 peoples.
• Support in all customer audits and regulatory authority inspections and Ensure timely completion of commitments from regulatory agency inspections
• Collaborated with department heads to establish goals and work plans.
• Trained and guided team members to maintain high productivity and performance metrics.
• Ensured compliance with relevant regulations by developing robust policies and procedures.
• Implemented new systems for better data management, leading to improved decision-making processes.

• Supervise overall Quality Control laboratory in absence of QC head with direct reporting of 9 persons of QMS and compliance.
• Leading QMS, Compliance and Document Cell section of Quality Control and Stability laboratories of Baxter Pharmaceuticals Ahmedabad Plant - Reporting of 14 persons.
• Leads and manages processes that provide oversight and guidance to monitor and assure compliance with quality management system and GxP requirements.
• Support regulatory authority inspections and partner audits & Ensure timely completion of commitments from regulatory agency inspections.
• Develop and owns Quality policies, Standard Operating procedures and standards governing GxP computerized systems and ensures compliance to relevant regulations such as Data Integrity standards, 21 CFR Part 11 and Annex 11.
• Ensure Data Integrity and Quality risk assessment of laboratory systems at site.
• Review of FDA Published FDA 483’s and Warning letter observation and ensure compliance wrt computerized system and Laboratory.
• Actively involved in execution and approval of change control Management, Investigation of deviations, batch failures, Market complaint, Implementation, and effectiveness of CAPA.
• Participating in Monthly quality meets and weekly operation meeting.
• Oversaw daily operations of the department, ensuring smooth workflow and timely completion of tasks.
• Applied strong leadership talents and problem-solving skills to maintain team efficiency and organize workflows.

• Participates for QUEST (Cultural transformation & Risk assessment), LABEXL18 of Lean lab concepts (to improve SLA and Sample to Analyst Ratio).
• QUEST initiatives and review of other company’s FDA 483’s and Warning letter observations and ensure compliance at site by providing training.
• Assigning and Tracking of Global CAPA for different site and its implementation.
• Operating Track wise (for QMS documentation), Documentum (for Document management) and Zytims (for Training and Analyst qualification management) software.
• Participates in Monthly Quality Review Meeting and monitoring of Quality metrics of all sites.
• Review of QMS document e.g. Change control / CAPA /Deviation, Laboratory failures i.e. OOS, OOT, OOC, Incidents, etc.
• Review of Stability Protocol, Hold time study sheet and Stability Summary sheet before regulatory Submission.
• Prepare the sites for the Audits and Audit management.
• Gap assessment between Quality Policies and Plant SOPs, prepare the Quality Policies.
• Participating in regulatory inspection e.g. USFDA and various other agency/customer audits.
• Participating in designing and finalizing Quality Policy, Global CAPA tracker and its implementation.
• Accountable for Data integrity review and QA oversight for QC department.
• New Quality initiatives and ensure the implementation thereof.

• Review of Analytical method validation data for various dosage forms e.g Tablets, Capsules, Inhalations, Nasal Sprays, Solutions, Injections, Ophthalmic etc.
• Responsible for planning and execution, preparation and review of analytical data. (Total 4 Persons team)
• Review and Approval of Analytical method validation and transfer report.
• Review of routine sample analysis for release for aerosol products (Stability and Finished Product).
• Review of Drug product characterization data for Nasal Sprays and inhalation products.
• Responsible for investigation of OOS,OOT and Laboratory incidences.
• To prepare SOP’s for use in aerosol analysis and instrument operating procedures.
• To provide training for trouble shooting in Aerosol analysis

• Responsible for planning and execution of analysis. (Total 12 Persons team)
• To prepare Stability reports, stability summary and Stability protocol .
• Review and approval of Stability analytical data, Stability reports, stability summary, Stability protocols , stability trend charts.
• Review of temperature data monitoring of stability chambers.
• Responsible for investigation and trouble shooting of OOS,OOT and Laboratory incidences.
• Responsible for Development studies e.g Thermal cycling, Temperature excursion and Photo stability in laboratory.
• Responsible for investigation of OOS,OOT and Laboratory incidences.

• Responsible for analysis of Finished product, stability samples and support activity.
• Responsible for analytical method validation for drug products.

• Responsible for analysis of Bulk samples, In process and Finished product samples.