Diptanshu P. Email & Phone Number

Lebanon, Nh, Us

Ohio, United States

• Led a quality team consisting of QA reviewers, QC analysts and Quality inspectors providing overall guidance, training, scheduling, assisting with hiring process.• Investigated incident associated with production operation and provide on-time SME support to the production unit.• Collaborated with production, QA team and cross functional teams to address quality-related issues promptly.• Investigated deviations, out of specification results as part of team to determine product impact and find out root cause and corrective-preventative measures (CAPA).• Reviewed batch manufacturing records, QC analysis results, quality patterns, deviations for completeness, accuracy, data integrity and took determination actions like hold, release, and rejection of the batch.• Identified opportunities for process improvement and contribute to initiatives aimed at right at first time (RFT), enhancing the efficiency and effectiveness of in-process QA activities.• Participated in cross-functional meetings and provided training to production personnel on quality standards, in-process monitoring procedures and the importance of adhering to cGMP.

Riverview, Michigan, United States

• Performed QC data review of Active Pharmaceutical Ingredient (API), Raw Materials, Starting Materials, In-process samples and finished products.• Verified analytical tests result calculations against the specifications and test methods for data discrepancies, escalating the issue to the manager.• Participated in investigations of out-of-specification or out-of-trend analytical results. • Ensured that documentation is in accordance with established SOPs and followed ALCOA ++ principles.• Verified that laboratory instruments are calibrated, analytical data records and their logbooks are maintained.• Worked closely with QA department to address any quality related issues and facilitate compliance. • Ensured that all testing activities carried out within QC lab comply with relevant regulatory practices and proper use of personal protective equipment (PPE). • Collected samples of raw materials, in-process materials and finished products during various stages of manufacturing of solid dosage form as well as Sterile-Aseptic manufacturing processes.• Identified and analyzed data patterns and quality discrepancies in the QC analysis and its reports.

Steinbach, Manitoba, Canada

- QA lead for an atypical situation and investigations associated with production operation including floor presence to provide on-time support, assessment of product impact using problem-solving tools, determination of root cause, corrective and preventive measures (CAPA)- Make sure current copy of approved change control, deviation reports (DR) and Exceptional Reporting (ER) attached to client documentation for the finished products, CMO and Bulk products- Ensured all documentation for CMO, bulk and finished goods are reviewed, current before release- Developed and delivered technical training presentation for the new employee orientation program- Prepared quality assessments, technical reports, system improvement and special projects assignments - Supported regulatory audits, lean initiatives, 5s principals and continuous improvement (CI) ideas- Reviewed, prepared and approved GMP documents such as batch records, CoA’s, CoM’s, SOP’s and artworks- Assessed and conformed the product quality by reviewing batch records and analytical results using the Laboratory Information Management System (LIMS), SAP and electronic review-electronic signature (ER-ES)- Reviewed and ensured various types of documentation for completeness, the accuracy of data including manufacturing records and quality control laboratory results for bulk and finish product releases- Reviewed manufacturing and packaging batch records for completeness, accuracy, initial contacts (IC’s), exceptional reports (ER’s), breakdowns, batch reconciliation and ensure before release- Prepared annual product quality report (APQR) using SAP, exceptional reports (ER’s), batch records - Maintained reject notification management system for change in artwork rejects, discontinue product rejects, experimental material rejects, in-process and finished products reject

Steinbach, Manitoba, Canada

- Performed timely data review for quality and integrity of API drug substances, excipients, in-process materials, finished products, stability study, analytical method validation documentation, microbiological testing of cleaning validation and verification- Ensured accuracy, completeness and neatness of analytical documentation- Verified documented information such as reagent name, expiry, instrument calibration dates, logbook entries, calibration due dates, batch no., lot no., lab no., company make, calculation check done by, verify by, control charts are present, complete and accurate- Reviewed wet chemistry tests like ID tests A/B/C/D, Heavy metals ICP-MS, residual solvents, assay, impurities, solubility, particle size, moisture, LOD, ROI, bulk density, compressibility and true scan tests for raw material using USP,JP and EU pharmacopoeia- Audits analyst’s lab books, HPLC/GC solution books and wet chemistry solution preparation books for calculation, procedure, quantity and expiry dates- Reviewed and verify of all results for HPLC, GC AND DISSOLUTION are comply as per specification and reported on PSF - Reviewed pharmaceutical as well as natural health product raw material (NHP), coating suspension, finish products documents and tests by using USP, EP and validation protocols - Ensured for buffer media preparation expiration date, quantity, the material used and proper documentation as per STM- Identify documentation error, OOS, OOT and help supervisor to find out rootcause- Maintained APQR for each product for Assay, moisture, dissolution, total impurity and weight variation and content uniformity- Ensured and verify environmental monitoring microbial count results and total air born particulate matter report for area and equipment swabbing- Reviewed equipment cleaning verification reports for its residue determination of AIP, microbial growth and CIP-100 residual results

Toronto, Ontario, Canada

Mississauga, Ontario, Canada

Haccp Quality Auditor Certificate, Medicinal And Pharmaceutical Chemistry

M.Sc. Chemistry (Evaluated By Wes Canada & Usa), Chemistry