Quality Control, AMV All Activities & Development

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ASHOK BALU AMALE

**********@**********.***

Mobile: +91-996*******/+91-909*******

Result-driven high skilled & dynamic professional; Around 14 years of extensive experience: targeting senior level assignments in Pharma Analytical Method Validation, Verification & Transfer, Regulatory Queries, Quality Control, Quality Assurance for Formulation Products/API.

Method Validation for the N-Nitrosamine impurities & NDSRIs by LCMS.

Location Preference: PAN India/Abroad

Profile Summary

Having around 15 years of experience in Quality Control, Analytical Development Laboratory and Method validation department. Working for regulatory markets. Method Validation for the N-Nitrosamine impurities & NDSRIs by LCMS. Currently working as Sr. Executive in Rubicon Research Ltd. & handling Analytical Method validations, Verifications & Transfer activities, Regulatory Queries from August 2017. Responsible for independently handling for projects for regulatory markets as well as for Domestic market. Working on different kinds of Formulations, like Solid & liquid orals, suspensions, Nasal etc. Expertise in method validation, verification and method transfers. Having exposure of Good documentations practices, GxP & Regulatory queries & QMS (part of investigation team). Preparation of method validation, verification, transfer protocols and reports (within & outside organization). Good Analytical hand on Analytical instruments. Previously worked with Alkem Laboratories Ltd., Cipla Ltd., Lupin Ltd. & Unimax Laboratories Pvt. Ltd.

Collaborated with management and supervisory personal from Research and Development team, AMV, Quality Control, Quality Assurance to resolve problems affecting product quality, collaboration included reacting, investigating and follow up for non-conformance of issues.

Appeared for multiple regulatory audits from USFDA, MHRA, regulatory agencies.

Facilitated CAPA commitments & effectiveness checks, including initiation tracking, trending, and closure track and management of deviations/ investigations/Incidences/CAPA system in track-wise.

Actively involved in the continuous improvement process of quality.

Excellence in transforming quality function into a robust quality unit that delivers maximum output with zero defects.

Expertise in team building, team handling, mentoring, team work success fundamentals, alignment and co-working with cross- functioning technical departments of organization like QC, QA, Method Development.

Profile Summary

Core Competencies

Method Validation for the

methods of NITROSAMINE

& NDSRIs by LCMS.

Analytical Method Validation

/Verification/Transfer/Regula-

tory Queries/ Quality Control.

Strategic Work Planning &

Leadership

Project Management

QMS, Data Integrity &

Compliance

Team Building

& Lab Training

Process Improvement In

Lab

Faced different Audits &

Inspections

(USFDA/TGA/MHRA)

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Work Experience

Rubicon Research Ltd. (USFDA, MHRA, TGA): Duration: - June 2017 – March 2019 & Since August 2020 – Till date at Ambernath, Thane as Senior Executive in Analytical Method Validation (AMV) Department.

Key Result Areas:

Responsible for Analysis and monitoring of Analytical Method Validation, Analytical method verification and Analytical method transfer in QC laboratory from AMV department for finished products (assay, RS and dissolution, Residual solvents by GC/GCHS, Particle size by Malvern 3000) and APIs for US market and Domestic market.

Method Validation for the N-Nitrosamine impurities & NDSRIs by LCMS.

Handling a team of 4-6 person independently.

Responsible for AM validation, verification and transfer, protocol and report preparations, review & approval as per SOP for finished products and APIs.

Validation/Verification data review.

Daily planning of AM validation and verification activities. Online analysis monitoring.

Adherence to GDP, GLP in laboratory.

Products handled: Tablets, Capsules, Oral suspensions, Oral Solutions, Nasal Formulations

& all related cleaning validation methods.

Deficiencies, Queries related to methods received from clients or regulatory agencies.

Attending meetings related to method deficiencies/queries with clients, related to projects for project status with PMI’s and achieving milestones.

Independently handling of analytical project. Responsible for Handling QMS i.e. incidences, investigations, change controls etc.

Calibrations of Analytical instruments.

Review of all type of analytical Raw data, validation protocols and reports.

Maintain data (retrieval & archival) as per Good Laboratory practices, compilation of AMV data.

Follow up with AD department for various prerequisites required for validation activities.

Assist subordinates in trouble shooting.

Exposure of Chromeleon, Lab solution software.

Training to new comers.

Successfully Designed, Prepared, Implemented and Validated online calculation report templates in Chromeleon software required for Assay, Dissolution, RS and Residual Solvents method Validation e.g., Method validation templates like Precision, Accuracy, Linearity etc.

Successfully handling online documentation software “Samwed” for protocol-report preparations, E-log books & for QMS.

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Alkem Laboratories Ltd. (USFDA, MHRA): Duration: - March 2015 – April 2017 at Taloja, Thane as Research Scientist in ADL Department.

Key Result Areas:

Assay, Dissolution & RS Method Validation for drug products - Tech transfer/Method transfer to QC/plant locations.

Method validation Protocol, validation report preparation & tech transfer report preparation.

FDA Query Analysis related to methods.

Method verification of new pharmacopeial methods.

Analysis of Routine Formulation Batches of Tablets, Capsules, Powders for oral suspensions Oral solutions and Oral suspensions received from F&D for regulated markets. (Assay, Dissolution, RS etc.)

Analysis of Working Standards (Working Standard Qualification).

Analysis of plant samples.

Responsible for calibration of instruments like Analytical Balance, pH meter, HPLC.

Performed Excipient compatibility study.

Worked for regulated markets.

Exposure of Empower and Chromeleon software.

Maintain data as per Good Laboratory practices, compilation of AMV and routine data.. Cipla Ltd. (USFDA, MHRA): Duration: - December 2010 – March 2015 at Vikhroli, as Management Staff in ADL Department.

Analytical method transfers to other Cipla units & Cipla Loan License (LL) units.

Assay, Dissolution & RS Method Validation for Drug products.

Method validation, verification of all methods (either instrumental or classical), which are updated in current pharmacopoeias (IP, BP/EP, USP). Reporting the deficiencies in method verification if any, and report to seniors for further updation.

Analysis of LL unit samples, Market complaint samples Containing Tablets, Capsules, Creams and Ointments, IV/IM injections, Ophthalmic, Oral suspensions & solutions.

Making working standards (WS) using all Pharmacopeial Reference standards (RS).

Making Test standards (TS) using Working standards.

Guidance to juniors for Analysis.

Exposure of Chromeleon software.

Lupin Ltd. (USFDA): Duration: - June 2009 to December 2010 at Tarapur, Boisar, as Senior Quality Control Officer in QC Department.

Sampling.

Analysis and reporting results of raw materials, finished products and intermediates.

Reaction monitoring and Analysis of intermediate products in in-process section.

Preparation and maintaining documents of reserve samples.

Calibration of instruments like HPLC, pH meter, analytical balance as per GLP standards.

Exposure of Chromeleon software

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Unimax Laboratories Pvt. Ltd.: Duration: - June 2008 – June 2009 at Tarapur, Boisar, as Quality Control Officer in QC Department.

Sampling.

Responsible for carrying out Raw Material Analysis and Inprocess Analysis.

Analysis of final products.

Procurement of chemicals, working standards, primary standards, HPLC columns required for Analysis.

Preparation and maintaining documents of reserve samples.

Calibration of instruments like HPLC, pH meter, analytical balance as per GLP standards. PROFICIENCY IN FOLLOWING ANALYTICAL INSTRUMENTS:

1. LCMS with SCIEX-OS software

2. HPLC (Waters-Empower & Dionex, Shimadzu, Agilent with Chromeleon & Lab Solution Softwares)

3. GC (Shimadzu, Varien with Chromeleon Softwares & YL GC instrument with YL-Clarity Software)

4. FTIR spectrophotometer (Alpha Bruker-Opus Software & Shimadzu-IR Solution) 5. UV Visible Spectrophotometer (Shimadzu with UV Probe & Perkin Elmer with UV Solution Softwares)

6. Karl Fisher titrator (Metrohm, Metler Toledo)

7. Potentiometer (Metrohm)

8. Polarimeter (Rudolph)

9. Thin Layer Chromatography.

9. Particle size analyzer (Malvern 3000)

10. XRD (ALPHA BRUKER)

CERTIFICATE COURSES & AWARDS:

- Certificate Course in MS-CIT.

- English Typewriting 40 wpm.

- NCC “C” certificate passed.

- One day Seminar attended for ‘Good chromatography and Integration’ organized by Thermo.

- Two days seminar attended, organized by Spinco Biotech, Shimadzu.

- Two times awarded in Rubicon Research by “Spot Award” for extraordinary work.

- One time awarded in Rubicon by “Milestone Award” for completion of Regulatory submission work within stipulated time period.

- Awarded as “Quality Hero” for implementation of models for the reduction in QMS. 5 of 5

EDUCATIONAL QUALIFICATION:

1. Master of Science in Analytical Chemistry, Naurosjee Wadia College, Pune University, First Class, in year 2008.

2. Bachelor of Science in Chemistry, SSC College, Pune University, First Class with distinction, in year 2005.

PERSONAL INFORMATION:

Date of Birth : 14th December, 1984

Gender : Male

Mother Tongue : Marathi

Marital Status : Married

Languages Fluency : Marathi, Hindi & English.

Permanent Address : 2A-15, Ambika Nagar CHS Ltd,

Saraswat Colony, Near Panchayat Bawadi,

Dombivali (East) – 421 201, Maharashtra, India.

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