Tushar Kashalkar

• Ensured that the Quality Management Systems and processes followed at site meet the J&J quality policy, J&J standards, local procedures, and current applicable cGMP guidelines.
• Assisted all the Stakeholders on site in implementing Quality Systems complying with applicable regulations.
• Active participation & implementation activities in Deployment of 'Handling of controlled substances' at site in a compliant way to meet local and global regulations.
• Handled product, instrument related & various other nonconformances (OOS,OOT etc.) as per SOPs.
• Implemented & reviewed the Corrective & Preventive Actions as per the SOPs resulting from the deep investigations of nonconformances.
• Handled and implemented the changes through Change Control.
• Training personnel on Quality System SOP’s, cGMP topics & provide cGMP advice.
• Participated in the internal audits as co-auditor & ensured that the Internal Audits are conducted at regular intervals.
• Conducted the check rounds & Gemba walks along with Internal Audits to keep site Inspection Ready.
• Kept oversight on the monthly Preventive Maintenance & Calibration Activities as per the SOP.
• Implemented the Compendial Changes by performing the gap assessments with existing Quality Systems & their timely implementation.
• Periodically approve the documents related to site pest control, various data backup activities, alarms generated in stability chambers & kept oversight.
• Periodically Presented various Quality Matrices to managers and leaderships to to provide better Quality oversight and risks (QSMR, CRB & QIPs)
• Quality related data trending

· To keep the lab records and documentation in compliance with ISO 15189:2012 (NABL)

· To ensure the Good Laboratory Practices (GLP) according to the guidelines provided in ISO 15189:2012 (NABL)

· To participate in NABL audits & Management Review Meetings.

· Successfully faced 2 NABL audits (currently facing NABL internal audit), CAP audit

· To handle investigation and root cause analysis for non-conformance

· To handle CAPAs and change control pertaining to lab function

· To evaluate Vendors and relative service providers and rate them accordingly.

· To coordinate with doctors, sales team & patients when necessary.

· To perform all the QC related tests and maintaining their records i.e., TAT analysis, LJ charts and report to superiors about daily status of work.

· To evaluate all the results and keep record of them daily

· To participate in Quality Compliance Program like EQUAS, QAP and NABL & maintain their record.

· To add new tests and developing their SOP’s

· Constantly reviewing the SOP’s and changing and documenting them as per their requirements.

· To perform ELISA for blood samples

· To perform GC-MS for Urine samples

· Identifying and Gathering Evidence

· Documenting Evidence

· Preserving Evidence

· Testing Evidence

· Reporting Findings

· Submissions of documents

· Analyzing samples, such as hair, body fluids, glass, paint and drugs, in the laboratory

· Sifting and sorting evidence, often held in miniscule quantities

· Attending and examining scenes of crimes

· Recording findings and collecting trace evidence from scenes of crimes or accidents

· Reviewing and supervising the work of assistants

· Presenting results of work in written form or by giving oral evidence

· Justifying findings under cross-examination in courts of law

· Researching and developing new techniques

· Liaising with team members

· Coordinating with outside agencies and offering expert advice

· Analyzing and interpreting results

· Liaising with police to establish forensic strategies

· Writing detailed reports for court

Instructing on procedures for cases