Quality Assurance Data Integrity

CURRICULUM VITAE

Swapnil Ashok Patil

Mobile: +91-989*******/989-***-****

E-Mail: ***********@**********.*** linkedin.com/in/swapnilpatil11072019

CAREER PROFILE

Proactive and results oriented professional extending distinguished career of about 21 + years in pharmaceutical industry, handling Quality Assurance, Quality control and Compliance team. Currently spearheading functions in Quality Assurance with Watson pharma R&D QA (Teva )

Key Skills

Profile Summary

QA Compliance and Data integrity management

OOS/OOT/Deviation

Investigation

Audit compliance

Release of Finished product/Raw material

Analytical Method Validation QA compliance

Stability Study compliance

Cleaning validation

APQR Review and monitor significant changes in data.

Training Management

Analytical & Micro testing compliance.

21+ years of Ambitious & Performance driven experience in pharmaceutical sectors including planning, execution and successful compliance of OSD (Tablets, Capsules & Creams lotion) for US, Europe and Asia pacific market.

Effectively managed Data Integrity Issues with appropriate CAPA.

Effectively handled “OOS/OOT/OOE investigation as per USFDA & MHRA guideline.

Effectively managed Deviation & Lab incidence investigation and its trending as per predefined frequency to minimise laboratory errors related to human error and instrument error.

Well versed with Pharmaceutical Quality Systems, Regulatory requirement. i. e. Track wise, EDMS, Ample logic & LIMS

Having brief experience in finished product testing, review and release in SAP system.

Review and approval of Master BMR & BPR and process validation protocol.

Review and approval of Equipment qualification document.

Cleaning validation study monitoring for chemical and Micro test.

Management of lab compliance activities e.g., IQ/OQ/PQ, Calibration and preventive maintenance of lab instruments like Balance, HPLC, UV, Incubator, Dissolution tester etc.

Review & approval of micro testing data and its QMS compliance.

CAPA management and its closure in Track wise system.

Subject Matter Expert in analytical procedures and specification and provide analytical support to the team.

Routine Quality audit of CMO and to take follow-up for timely closure of CAPA actions. Ensure that audits are executed as per schedule.

Review and approval of Analytical Method Validation protocol.

Review and approval of stability study summary report.

Well aware about Data integrity concept and its compliance part.

GLP, GMP & Data Integrity training management as per defined frequency.

Education and Certification

M.Sc. (Chemistry) - 2002, from Shivaji University with FIRST CLASS.

B. Sc (Chemistry) - 2000 from Shivaji University with FIRST CLASS.

Post Graduate Diploma in Drug Regulatory Affairs (Formulation) 2014, from Institute of Pharmaceutical Management, Vashi Thane

USP Course: Foundation of GMP: Auditing

USP Course: Foundation of GMP: Data integrity and computer system validation.

USP Course: Foundation of GMP: Qualification

USP Course: Foundation of GMP: Quality risk management

USP Course: Foundation of GMP: Validation

USP Course: Foundation of GMP: Deviation, RCA tool, CAPA and sequence flow for handling of nonconformance in GMP Environment

USP Course: Foundation of GMP: Heating, ventilation and HVAC System

USP Course: Foundation of GMP: Water System

LinkedIn Course: Leading in Uncertain time

LinkedIn Course: Introduction to Six Sigma Black Belt

Career Timeline

Cipla Ltd.,GOA Verna

Ind. Estate as

Management

Staff – QC

Dr. Reddys Lab Ltd.

Hyderabad

Jr. Manager QC

Umedica Laboratories pvt Ltd & Spentose Vapi

Gujarat, Lead-QMS

Nov 2002-

Feb 2004

Feb 2004-

Oct 2004

Nov 2004-

April 2007

April 2007 –

July 2020

August 2020-

Aug 2024

Sept 2024–

Till date

August 2020-

till date

Glenmark Pharma

Mapusa Goa

Executive QC

Sandoz Pvt Ltd,

Thane

Assistant Manager Quality Assurance

Teva (Watson) R&D

Ambernath Mumbai

Assistant Manager

Quality Assurance

Major Audit Faced

USFDA (2016, 2018), MHRA, WHO, EDQM, TGA

Sept- 2024 – till date: Teva Pharma (Watson pharma )

QA compliance activity with respect to QMS & GMP document review in current domain.

QA Data integrity key person for Data integrity risk assessment of site activity.

Performed risk assessment of all department with respect to process followed and instrument data generated.

Investigated Data integrity issues with other team member and CAPA identified to avoid the same issue.

DATA Integrity awareness training given to site.

Review and approval of Analytical method development report review, protocol review and AMVR report approval in Glorya system.

Review and approval of Nitrosamine risk assessment report.

Review and approval of Nitrosamine impurity method development report.

Review and approval of Method validation protocol, Text execution data and report.

AMTR review and approval in GALORYA system.

Conducted Frequency based Vendor Audit, report preparation, compliance report review and further communicated for CAPA action plan.

Reviewing and approving supplier Quality Technical Agreements.

Identify areas and topics that need procedures to be set, training to be conducted, and document procedures to be executed in a timely manner.

Approve SOPs for Quality assurance and other departments.

To closely monitor lab compliance and its trending and Data integrity issues.

Key Achievement:

Reduced Human error with continuous improvement in CAPA action follow-up with cross function team.

ALCOA++ training conducted to shop floor people with identified examples to minimise Data integrity issues.

June 2021 – Aug 2024–: Umedica Laboratories Pvt Ltd (Lead QMS, QA)

Analytical and production QA compliance and Data integrity activity management, QMS, GMP document management team in current domain.

Responsible to lead the teams, guide them in decision-making, develop, plan and execute activities in Quality assurance department.

To perform and coordinate with QC and Production team for each OOS/OOT investigation, its CAPA and effectiveness management.

Review and approval of Master BMR, BPR and Process validation protocol.

Conduct Vendor qualifications- External Audit compliance.

Cleaning validation activity monitoring and its protocol and report approval.

Water system qualification and periodic monitoring of water quality for chemical and Microbiological test.

Reviewing and approving supplier Quality Technical Agreements.

Identify areas and topics that need procedures to be set, training to be conducted, and document procedures to be executed in a timely manner.

Approve SOPs for Quality assurance and other departments.

Conduct Induction and Training programs.

Reporting of KPIs to management on monthly basis.

Submission for Regulatory Audits and provide Compliance Report for regulatory audits.

Prepare and get prepared the documents that may be required to be compliant with applicable FDA/cGMP requirements.

Approval and authorization of Analytical Protocols and Reports, Method Validations, batch test data, forms, COA’s, all documents where relevant.

Review and approval of Micro department SOP, Format and testing report.

Face Regulatory/Sponsor/customer audits and provide compliance.

Conduct Management review meetings and provide progress plan to management.

To monitor overall QMS related activity and its closure within timeline.

Stability study report review and follow up for any Stability testing noncompliance against specification.

To review and coordinate with different section for FAR related investigation and its final closure.

Coordinate with cross function teams if required for Batch release related activity which help to achieve monthly target.

Change control and pending CAPA evaluation on monthly basis.

To maintain GMP & GLP environment in production as well as in QC department.

To closely monitor lab compliance and its trending and Data integrity issues.

Key Achievement:

Reduced open Deviation/OOS/CAPA number with continuous follow-up with cross function team and guided them to close existing action before timelines defined.

Successfully carried out Desktop Audit of 9 API and 14 Excipient vendor with managing routine activity.

Retrospective review of previous three-year OOS investigation report done and rectified identified gaps with proper justification.

All system related SOP reviewed with respect to procedure given Vs Actual practice and gap with respect to current regulatory requirement.

Aug. 2020 – June 2021: Spentose Pvt Ltd (QA-QMS)

Responsible for Quality Systems implementation and management, Current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP) at Sites.

SOP Gap assessment with respect to regulatory updates as well as procedure Vs Actual practice.

To manage all OOS/OOE/Deviation investigation activity and its final approval in new QAMS system within specified timeline.

Laboratory incident and OOC management with corrective action to avoid reoccurrence.

Change control coordinator and its CAPA management

To Prepare, review and approval of document related to GMP & GLP Audit Observations and its compliance.

As per schedule, Conducted Production & Lab visit to ensure GMP and GLP environment and Data integrity.

As a responsible member of QA team, Define & Implement strategies for documentation review & control. Involved in Preparation, Review, and approval of SOP’S.

Key Achievement:

•Successfully reduced repetitive human error and instrument error during QC testing activity

up to 21 % from 38 %.

•Implemented DMS system for e-preparation of Specification/ test method, BMR and analytical protocol

and its format.

•Trained all QC and shop floor team about GMP and data integrity issues.

Jan. 2015 – July 2020: Sandoz Pvt Ltd (A Novartis company) Assistant Manager, QA

Overall QA compliance activity of Global method validation Center.(GMVC)

Reviewed and approved Method Validation/FD study Protocol & its report.

QA round taken in different department like QC, Production, Engineering, Warehouse to maintain GMP and Data integrity in all areas.

Effectively managed all OOS/OOE/Deviation investigation activity and its final approval in Track wise system within specified timeline.

Review and approval of Master BMR and BPR in SAP system.

Coordinate with production team for cleaning validation and routine monitoring for chemical and Micro test.

Investigation and audit outcome CAPA’s follow-up, extension and its closure done within time frame.

Based on severity of OOS/OOE/OOT, escalation to higher management and FAR filling.

Laboratory incidences and OOC investigated and corrective action were taken to avoid reoccurrence.

Participated in Site GMP Audit preparation and post audit compliance process.

Executed Audit trail review & User management activity of Chromelon software as QA Admin.

As per schedule, Conducted Production & Lab visit to ensure GMP and GLP environment and Data integrity.

Tracking of instrument calibration/preventive maintenance annual schedule.

User management in stand-alone systems and Creation, modification, activation and deactivation of user profiles.

Handled Change control assessment and its evaluation through Track wise system.

Key Achievement:

•Successfully investigated about 500 OOS/OOE/Deviation/Lab incidence and closed related all CAPA’s

within specified timelines in Track wise system.

•Successfully identified root cause and suggest appropriate CAPA during critical lifesaving drug OOS

investigation activity.

•Conducted Self Inspections/Internal Audits and maintained the Compliance status of Site for

Customer/Regulatory Audits.

April 2010- Dec. 2014: Sandoz Pvt Ltd (Sr. Executive, Quality Assurance)

Finished product and working standard preparation Analytical testing data and BMR were reviewed & Approved in SAP system as per ALCOA+ principal.

Reviewed and approved stability test data and its report for any discrepancy.

Coordinate with Regulatory team for stability data submission commitment.

During product launch in new country, Prepared Specification and MOA based on approved Dossier document.

As a contributing member of QA team, Define & Implement strategies for documentation review & control.

Key Achievement:

•Supported organization while USFDA inspection CAPA implementation. e.g., Standalone system daily

backup taken for one month. e.g., UV spectrophotometer, XRD etc.

April 2007 – March 2010 Sandoz Pvt Ltd (Sr. Executive Quality control)

Performed analysis of in process validation blend sample, finished products stability samples without any human error and DI issues.

Closely Worked together with cross function team to implement Good Documentation Practice (GDP), reviewed multiple issues and impact of the same, and take corrective actions.

Reviewed and approved SOPs and Standard Formats for executing QC work tasks ensuring these are current and meet company and international regulations.

Reviewed & Approved test executed data and final report with following ALCOA+ principal to assure quality of raw materials, in-process products, and finished products.

Reviewed calibration and qualification document of QC Instrument e.g. HPLC, Dissolution, UV spectroscopy and Analytical balance & PH meter.

Maintained laboratory chemical inventory and also ensured expired chemical, reagent, buffers solvent.

Reviewed electronically generated chromatographic data as well as all instrument audit trial for any data integrity.

Key Achievements

Actively Supported QC instrument qualification team during K2 QC lab setup and for SOP’s preparation.

As a reviewer managed 12-15 Analyst staff to verify and ensure all daily QC testing tasks are completed as per schedule and in compliance with SOPs and batch record requirements.

Nov’2004 – April’2007: Dr. Reddy’s Lab Ltd., Hyderabad as Jr. Manager QC

Executed water sampling and its chemical analysis, In-process validation sample analysis, finished products and cleaning validation sample analysis without any laboratory error.

Used LIMS system for online test execution and its calculation purpose.

HPLC, UV spectrophotometer and dissolution system calibration performed as per pre-approved schedule.

As per regulatory requirement, provided analytical test data of released batches to fulfil regulatory commitment.

Key Achievements

Closely worked with line manager during Baddi plant Lab set-up for 3 month (Installation of laboratory instrument and its IQ/OQ/PQ activity) and given training to new analyst about GLP practices.

Feb 2004 – Nov’2004: Glenmark Pharma QC Executive

Executed analysis of creams and lotions finished products and stability samples with following GDP.

Calibration of KF-tiltrotor, Analytical Balance, UV spectrophotometer and Dissolution tester were performed without any OOC.

Prepared New SOP’s as a part of new lab set up. e.g. Operation and calibration of Laboratory oven, stability chamber, Sonicator, water bath, PH meter.

Executed qualification and maintained Stability chamber in use condition for stability Study sample management (creams and lotions).

Key Achievements

Complete stability study management done starting from chamber installation to stability protocol and schedule preparation and its test execution for tablet/capsule & creams.

Nov’2002 – Feb’ 2004: Cipla Ltd. Goa Management Staff

Carried out in process and finished product sampling activity as per business SOP

Performed In-process and Hold time study and cleaning validation samples analysis.

Performed PH Meter, KF tiltrotor, analytical balance calibration before executing routine test analysis.

Always followed GLP and standard operating procedures related to a laboratory/ manufacturing environment.

Key Achievements

Learned basis GMP and GLP knowledge and instrument functionalities and carried out in process and finished product testing e.g., Hold time study, Blend uniformity, water content, friability, Physical parameter, Assay, Content uniformity and Dissolution.

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