Samriti Sharma Email & Phone Number

Brampton, On, Ca

· Provide Quality Assurance support and oversight of Manufacturing Processing areas, through Shop Floor engagement (Floor Presence, Functional Area Audits, Compliance Meeting participation, Online batch record review).· Responsible for the execution of quality checks (Startup approval, in process and end of batch checks, AQL inspections and Special Testing Request (STR).· Notify QAIP and packaging personnel of any deviations found during the review of in-process batch documents. Ensuring all corrections are made in the appropriate manner.· Provide immediate direction for potential quality issues on the shop floor including first assessment of potential deviations and initial determination of product impact, containment, immediate corrective actions and escalation. Also supports the investigative phases related to manufacturing process events, and implementation of Corrective and Preventive Actions (CAPAs). Also initiate and process deviations.· Perform sampling, inspection and physical testing on in process/investigational samples according to SOPs.· Audits logbooks for completeness and GMP compliance.· Perform line clearance per established procedures also giving line clearance certification.· Perform in process testing/inspection where required.· Perform annual inspection of reserve/retain samples.· Prepare composite samples (laboratory and reserve); delivers samples to required area(s) and controls storage and disposition of reserve samples.· Responsible for the daily calibration of all QAIP Manufacturing instruments and coordination with the Electrical Instrumentation group for any internal and external calibration.· Also involved in batch release activities.

Mississauga, Ontario, Canada

· Involved in primary and secondary packaging operations · Inspection of the products as per SOP· Performing Line Clearance Activity· Perform daily balance calibration· Responsible for collection of representative samples for testing, retention, stability and client with relevant paperwork

Mohali, Punjab, India

· Initiated, processed, and closed Quality system elements: incidents and deviations, performing immediate impact assessment. Followed by performing investigation, using various tools for Root Cause Analysis, and suggesting appropriate CAPA. Also involved in CAPA tracking and ensuring effectiveness of CAPA· Initiated, processed, and closed Change Management Systems (Change Controls) · Initiated, processed, and closed Out of Specifications (OOS) and Out of Trend (OOT), including Phase I & II investigations, batch disposition and CAPA handling for the same · Initiated, processed, and closed Product Complaints and Product recalls.· Communicated with other departments (Production, QC, IT, Material management, purchasing, etc.) for GMP related concerns and issues in regular meetings· Conducted compliance promotion activities (like internal audits), inspections, compliance verifications, investigations, ensuring GMP and SOP compliance.· Performed product review (rPQR)· Reviewed stability study protocols and reports· Performed trending of Quality issues and prepared Monthly Quality Reports. Also presented the same to senior management· Reviewed, Prepared and updated SOPs subjecting the identified GAPS.· Provided one on one coaching to packaging support staff i.e. mechanics to improve Compliance, RFT and good documentation practice. Also Maintaining the training record of personnel

Solan, Himachal Pradesh, India

· Involved in facility qualification and revalidation (Sterile production Line). · Assisted in validation of Equipments of production line (Sterile Dry Powder Injectable) and Utility supplies (AHU, Water System, Steam generators). Also, provided support in the Media Fill Activity and visual inspector qualification.· Prepared Site Master File as per the current PIC’S guideline and master batch records· Performed routine floor audits and release of executed manufacturing/packaging documentation in as close to real time as possible ensuring GMP and SOP compliance. · Maintained sample and retention records program· Performed product review and prepared Annual Product Quality Reports (APQRs)· Involved in documentation and control of Master Documents. As well as approval and handling of artworks· Issued, Monitored, reviewed and archived production and QC logbooks.· Performed routine inspection of QA/Operations walkthrough/audit and provide coaching to improve compliance and GMP behavior

Solan, Himachal Pradesh, India

· Handled, calibrated and maintained analytical instruments (HPLC, UV Spectrophotometer, Dissolution test Apparatus, FT IR) for routine analysis as per IP, BP & USP· Experience in analytical testing of Raw Materials, In-process Samples, Finished Products and Stability Samples using techniques like HPLC, UV, IR, TLC, Dissolution, titrimetry· Performed verification of potency calculation of Master Manufacturing Record as required.· Assisted in Analytical Method Validation and Cleaning Validation· Prepared Normal solution, Reagents & Standardization of solution· Prepared and maintained working standards

Panchkula, Haryana, India

· Handled, calibrated and maintained analytical instruments (HPLC, UV Spectrophotometer, Dissolution test Apparatus, FT IR) for routine analysis as per IP, BP & USP.

Master'S Degree, Business Administration And Management, General, 70%

Activities and Societies: Total Quality management

Bachelor'S Degree, Pharmacy