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Swapnil Ashok Patil

Mobile: +91-989*******/702*******

E-Mail: ad334w@r.postjobfree.com linkedin.com/in/swapnilpatil11072019

CAREER PROFILE

Proactive and results oriented professional extending distinguished career of about 21 years in pharmaceutical industry and Currently handling Quality compliance activity. Key Skills

Profile Summary

Quality Compliance

QMS compliance

(OOS/OOT/OOE) & Incident

Management (Track wise)

Vendor Audit and compliance

Deviation & Change control

CAPA & Effectiveness check

Stability Study compliance

Analytical review & Release of

Finished product/Raw material

in SAP system.

Analytical Method

validation/Method Transfer and

FD study compliance

Regulatory Audit compliance

(USFDA, EU-GMP, MHRA, TGA, WHO)

Training Management (GMP & DI)

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

Review of APQR and escalation of any significant changes and its probable impact in product quality and major variation in Quality attributes to management in Monthly meeting.

Review and approval of System SOP’S and performed gap assessment of system SOP Vs practice followed during GMP activity.

Review of BMR, BPR and Process validation protocol and report.

Effectively managed Lab incidence investigation and it’s trending as per predefined frequency to minimise laboratory errors related to human error and instrument error.

Deviation and change control review, approval and its closure in system.

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

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

Review and approval of Equipment qualification document.

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

Review and approval of Environment monitoring and water analysis.

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

Review and approval of Analytical Method Validation protocol.

Carried out Self Inspection and its compliance.

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. 2

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. Career Timeline

Cipla Ltd.,GOA

Verna

Ind. Estate as

Management

Staff – QC

Dr. Reddys

Lab Ltd.

Hyderabad

Jr. Manager QC

Spentose Pvt Ltd. Vapi

Gujarat

Sr. Manager

QA-QMS

Nov 2002-

Feb 2004

Feb 2004-

Oct 2004

Nov 2004-

April 2007

April 2007 –

July 2020

August 2020-

June 2021

June 2021 –

Till date

t

Glenmark Pharma

Mapusa Goa

Executive QC

Sandoz Pvt Ltd,

(A Novartis

company)

Asst-Manager

Quality

Assurance/QC

Umedica Laboratories

Pvt Ltd, Vapi,

Gujarat, AGM-QA

Major Audit Faced

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

June 2021 – till date: Umedica Laboratories Pvt Ltd

Managing QA compliance activity with respect to QMS & GMP document issuance 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/OOE investigation, its CAPA and effectiveness management.

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

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.

Reporting of KPIs to management on monthly basis. 3

To participate in Regulatory Audits and Compliance Report preparation for regulatory audits.

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

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

Conduct Management review meetings and provide progress plan to management.

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

To maintain GMP & GLP environment 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.

• 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

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. April 2010 – July 2020: Sandoz Pvt Ltd (Quality Assurance)

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

4

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

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.

QA compliance of method validation, method verification and FD studies.

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

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

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:

• Supported organization while USFDA inspection CAPA implementation. e.g., Standalone system daily backup taken for one month. e.g., UV spectrophotometer, XRD etc.

• Successfully investigated 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 OOS investigation activity.

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

April 2007 – March 2010 Sandoz Pvt Ltd (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.

5

Key Achievements

• 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 (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)

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 (QC)

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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