Page* of *

ALKESHKUMAR PATEL

* ***** **,

Iselin,

NJ 08830

Contact no.:+1-216-***-****

E-Mail: ad3ljq@r.postjobfree.com

A Management Professional seeking Technical and leadership roles focusing on Quality Assurance, Quality Control Microbiology Laboratory Operations additionally Quality Assurance validation activity with a reputed organization.

Technical Skills:-QA/QC activities for the setting up new facility, laboratory, Quality audits, Regulatory audits preparation, training,

Professional Skills: - Quality System Management, auditing, Work distribution, Process capability studies.

Management Skills: -Strong analytical leadership, Sound Judgment and decision-making skills, Interpersonal management, inter costumer relationship within organization and teambuilding.

To work with an organization of a good repute, where many opportunities for contributing personal growth exist and where my skills can be utilized at their very best.

Management professional with strong background of over 30 years in Quality Assurance and Quality control field of API (STERILE AND NON STERILE) and DRUG PRODUCT (DRY POWDER INJECTABLE) Pharmaceuticals operations.

An effective communicator with excellent relationship management skills with strong analytical, leadership, decision-making, problem solving & organizational abilities.

Ability to manage the work distribution, day to day task of QA/QC trouble shooting, meets the release timelines, correspondence with inter departments and managing documentation as per current cGMP / GLP regulatory guidance.

Experience in Establishment of QA-QC functions, establishing procedures, Planning and executing Validations under cGMP compliance.

Experience in establishment of Quality assurance Management System (QAMS) procedures.

Experience in development, execution and Auditing / Review of Quality Control and Quality Assurance procedures and investigations like Deviations, Market complaint, OOS,OOC,OOT, Trend Analysis, Cleaning Validation, Process validation documents, raw data and other validation documents required for regulatory compliance and their review.

Conducting audits and preparing audit reports and regulatory compliance audit reports.

Well versed with current Regulatory guidelines and faced regulatory audits USFDA,MHRA,TGA, EDQM, WHO and CDSCO as a lead department person.

Expertise in Microbiological test analysis such as Sterility testing of sterile dry powder and drug product, water analysis, Microbiological Assay analysis of drug powder and tablet and injectable product, Microbial Limit test, BET and its failure investigation.

Performed Method validation of Microbial Assay, Microbial limit test, BET, Sterility test. AREAS OF EXPERTISE

CAREER OBJECTIVE

EXPERIENCE PROFILE

Page2 of 4

Dec 2006 to May 2023 LUPIN LIMITED-MANDIDEEP

May 2011 to April-2015 LUPIN LIMITED,MANDIDEEP (Manager-M1 QA) May 2015 to May 2023 LUPIN LIMITED-MANDIDEEP (Manager- M2 QA) Role:

Manager QA Cardiovascular API facility.

Responsible for overall QA functions at site.

Handling Analytical QA functions individually.

Responsible for all time audit readiness at site.

Ensuring compliance with applicable internal and external regulations, standards, policies and procedures related to the quality and regulatory status and performance of company operations.

Responsible for investigation of non-conformities like Market compliant, OOS, OOT, Deviations, Incidents, OOC to identify the root cause and implementation of CAPA.

Responsible for response of regulatory/Customer queries.

Timely release of batches to meet the business requirement.

Approval of all quality documents.

Responsible for Monthly review meeting at API.

Responsible for management notifications to corporate team.

Responsible for review, approval and implementation of Global CAPA and change controls.

Performing internal audit and ensure compliance.

To build strong quality focus across the site by imparting training, conducting workshops & in-house initiatives.

Handling EBMR Projects of API.

Ability to improve quality system and work efficiency.

Ability to handle regulatory inspection. (4 FDA and other regulatory as well as customer audits.

Thorough knowledge and experience of, QMS

(Changecontrol,Deviation,Reprocess,Rework,CAPA,marketcomplaint,Incident) Management review report, OOS, OOT, Risk assessment, Process validation, cleaning validation, Product recall, return goods, self-audit, market complaint, equipment qualification, site master file, Quality manual.

Responsible for failure investigation and its implementation of CAPA.

Responsible for Water system validation and Facility Qualification.

Submission of required documents of QA-QC to Regulatory department for DMF. Role:

Manager Quality Assurance department Sterile Cephalosporin API and Dry Powder injectable Facility.

Supervising the validation activity of QA-QC, Production, WH, engineering etc. departments with respect to preparation of protocol and reports.

Work distribution of QA functions and ensure the data review and completion of work.

Responsible for review and closure of change control, deviation, OOS, OOT, CAPA, validations, qualification, self inspection, training, market compliant, Reprocess / Rework, control sample management, review and release of batch,etc.

Responsible for failure investigation and its implementation of CAPA.

Responsible for Water system validation and Facility Qualification.

Submission of required regulatory documents of QA-QC to Regulatory department for DMF/ANDA.

Documentation & Data maintenance of QA-QC, production, WH, Eng. documents as per latest guidelines (cGMP, EU-GMP, FDA)

Responsible for new instrument qualification and detailed validation of software as well as hardware qualification with related to the instruments.

Review and Approval of Annul Product Quality Review (APQR) of API and Drug Product.

Coordination in Validation & Qualification activities of APIs.

Data Trending and Statistical Process Control (SPC) of APIs.

Imparting training to QA-QC personals for related QA-QC functions. CAREER SCAN

Page3 of 4

Jun 2008 to May 2011 LUPIN LIMITED, MANDIDEEP (Senior Executive-QA) Apr-2004 to Nov -2006 Alembic Limited (Executive, Quality control) Jul -1993 to Mar-2004 Alembic Limited (Microbiologist) Role:

Worked as IPQA Officer in Sterile Vial filling facility Plant Phase 2.

Responsible for Line clearance Aseptic Vial filling facility and packaging operation such as, visual inspection of filled vial, Labeling, packaging.

Review of deviation investigation, change control, OOT.

Water sampling.

Review of process validation protocol and report, Review of Autoclave, Depyrogenation tunnel, Dry heat sterilizer, Vial washing machine Qualification document.

Media filling activity and its report review.

Sampling of sterile API, Environment monitoring in Aseptic vial filling facility, personnel Monitoring, Settle plate monitoring, active air sampling, surface monitoring.

Review of Batch production and manufacturing record.

Review of HVAC qualification, water system qualification documents.

In charge of Microbiological Laboratory.

Attainments:

Involved in Regulatory audit like USFDA,MHRA and TGA. Role:

Worked as IPQA Officer in Sterile Vial filling facility Plant Phase 2.

Responsible for Line clearance Aseptic Vial filling facility and packaging operation such as, visual inspection of filled vial, Labeling, packaging.

Review of deviation investigation, change control, OOT.

Water sampling.

Review of process validation protocol and report, Review of Autoclave, Depyrogenation tunnel, Dry heat sterilizer, Vial washing machine Qualification document.

Media filling activity and its report review.

Sampling of sterile API, Environment monitoring in Aseptic vial filling facility, personnel Monitoring, Settle plate monitoring, active air sampling, surface monitoring.

Review of Batch production and manufacturing record. Attainments:

Involved in Regulatory audit like USFDA,MHRA and TGA. Role:

Microbial analysis of drug product i.e. MLT, Microbial assay, Vitamin assay, Sterility testing of drug product through filtration and direct method.

Documentation & Data maintenance of Quality control laboratory as per guidelines (cGMP)

Microbial limit test of excepiants, Liquid oral products, tablets, empty capsules.

Environment monitoring, media preparation and autoclaving of media.

Method Validation of Microbial Limit Test of excepiants, Liquid oral products, Microbial Assay test of Tablets. Disinfectant validation, Preservative efficacy test method validation. Role:

Microbial analysis of API i.e. Microbial assay, Sterility testing of Sterile API through filtration and direct method.

Documentation & Data maintenance of Quality control laboratory as per guidelines (cGMP).

Environment monitoring, media preparation and autoclaving of media.

Performed Media filling operation of Sterile vial filling matching.

Performed Chemical analysis such as pH, Melting point, IR, Sulphated Ash, Chemical Assay Through titration, Water content, description.

• Method Validation of Microbial Assay test of API. Dec 2006 to Jun-2008 LUPIN LIMITED, MANDIDEEP (Executive-QA) Page4 of 4

I have been approved chemist by Food and Drug Control administration. Gujarat state, Gandhinagar. In Microbiological Testing section.

Post Graduate in Master of Science (M.Sc.)in Microbiology from "Allahabad Agricultural Institute" Deemed University.

Graduate in Bachelor of Science (B.Sc.) in Microbiology from R.G. shah Science College, Ahmedabad, Gujarat University.

Computer Knowledge: Operating Systems: MS-DOS, Windows 2000 and Windows NT and XP, Windows Vista. Soft Ware packages: MS- Office 2000, power point and Adobe Acrobat Reader, SAP,QMS, Mini tab for Statistical calculations, SABA training software,

I have been attended several seminars at my professional front.

Date of Birth:25thApril 1971

Gender: Male

Nationality :Indian

Language: English, Gujarati, Hindi.

FDA APPROVALOF TECHNICAL PERSON

ACADEMIA

PERSONAL ATTRIBUTE

PERSSONALDOSSIER

Contact this candidate