Quality Control Continuous Improvement

VICKY RAHUL PATRAS

Manager – Quality Control

PHONE:

+91 - 896-***-****

E MAIL:

ad5zcq@r.postjobfree.com (personal)

ad5zcq@r.postjobfree.com (work)

CAREER OBJECTIVE:

To pursue a challenging career in

pharmaceutical sector where I can

develop and utilize my analytical and

managerial skills to lead a team

determined to work for quality and

compliance. I am willing to expand my

portfolio and take up opportunities to

achieve the organizational goals and

take them to next level with

continuous improvement and

maintaining quality culture.

PERSONAL DETAILS

DOB: 17 Aug 1984

Marital Status: Married

Religion: Christian

Languages: English, Hindi (Fluent)

Spanish, Marathi, Tamil (Beginner)

RESIDENCE

Permanent Address: 31, Rishipuram

3, Anand Nagar, Bhopal, (MP), India.

Current Address: F-106, KGEH,

Siruseri, Chennai, (TN), India

EDUCATION

University of Northumbria at Newcastle, Newcastle upon Tyne, United Kingdom

2009-2010 Masters in Analytical Chemistry (with commendation - A Grade)

Allahabad Agricultural Institute Deemed University (now known as SHIATS), Allahabad, India

2004-2008 B.Tech Biotechnology (Biochemical technology: 78.6% CGPA)

Bonnie Foi School (HSC) 2002-2003 with 59%

Bonnie Foi School (SSC) 2000-2001 with 57%

WORK EXPERIENCE

15+ YEARS OF EXPOSURE including 9 US FDA AND 5 OTHER REGULATORY INSPECTIONS

Quality including Non-Sterile / Sterile - OSD & Injectables) formulations.

R&D for Analytical Method Validations, Method Transfers, Development and feasibility studies, Exhibit batches Stability studies and stability for F-R&D projects and Pharmacopeial analytical method verifications.

Drug Discovery for New Molecule development.

Green field project for setting up QC lab for new pipeline products. Duration:

May (2016)–till date (current)

Recognitions:

Recognized with Pinnacle Award

(Highest Employment Excellence

Award at PAR) for my performance

during the year 2020.

Above & Beyond award for leading

FDA inspection at site in the year

2023.

Facilitated for USP Donar recognition

program.

Elevated to role changes and career

advancement multiple times during

the employment at PAR.

1. PAR Pharmaceuticals, India (An Endo company): - Working as Manager -Quality Control, duties involved:

Reporting to Head - Quality Control for Quality functions at laboratory.

Currently Group leader for Finished Product and Metrology department.

Previous role within PAR: Group leader for Raw Material, Packing Material, Cleaning Validation and AMV / Method Remediations for 3.5 years.

Responsible for life cycle management for laboratory instruments/ equipment & related software’s.

Lead and facilitate Regulatory inspections or any other internal / external inspections at Chennai site.

Overseeing the planning for routine analysis, and responsible for Usage decisions of FP, IP, HTS, RM, PM, Calibrations and Qualifications. Represents QC at plant operations for commercial

/ projects.

Handling laboratory QMS: Change Controls, Event investigations

(which includes Incidents, Deviations, LIR, OOS and OOT’s, etc.).

Writing, Reviewing Protocols, Reports, APQR, QMS trends and implementation of SOPꞌs.

Responsible to check and facilitate the discussions for regulatory submissions and requirements w.r.t to QC documents.

Maintaining GLP within the QC department and preparing Gap Assessment report w.r.t instrument equipped with standalone software in the laboratory.

Managing Change controls for writing/reviewing/approving in- house study protocols, specification and STP’s.

Planning and working collaboratively with cross-functional team of Analysts/Departments/CFT’s.

Responsible to implement quality system like LIMS, Track wise Digital, Master Control, Compliance wire, Ample Logic, SAP, etc. within the QC department.

Responsible for maintaining compliance with respect 21 CFR Part 11 within the QC laboratory.

Responsible for fulfilling the requirements w.r.t. QC for regulatory submissions and CRL responses.

Lead for Empower, SAP and LIMS / Lab Vintage implementation at Chennai site.

Responsible for planning & monitoring of operational and capital budget requirement of quality department.

Overseeing Audit trail review for all GXP instruments and Empower EDS 365.

Faced three FDA inspections during the tenure at PAR.

Have been involved in leading the expansion/creation of Quality Control laboratory (Greenfield project) for new molecules. Duration:

July (2012)-April (2016)

(India and Argentina)

Recognitions:

Recognized with UExcel (Employment

Excellence Award) for my

performance on Sterile Projects with

stringent deadlines.

Additional Responsibility while

working in Glenmark Quality India

and Argentina: Preparing and

strategizing the activities related to

effective quality systems for various

Glenmark facilities to face regulatory

audits like US FDA, MHRA, ENVISA,

etc. I had worked as a core team

member of Glenmark Quality to

prepare Glenmark Argentina (Sterile)

Oncology plant, India Goa OSD-SSD,

Indore OSD for regulatory inspections.

During my tenure with Glenmark I

have had a chance to face and get

through four FDA and various other

regulatory audits across the Glenmark

sites (Goa-2, Argentina-1, Indore-1).

2. Glenmark Pharmaceuticals Limited (India and Argentina): 2.1. Glenmark Indore, India (OSD): -

Working as Executive – Quality Control, duties involved:

Overseeing the routine planning for stability analysis for Exhibit batches.

In charge of all investigation for laboratory incidents, LIR, OOS and OOT’s, etc.

Filling incidents through SAP and investing as per the standard operating procedures.

Responsible to check and facilitate the discussions for regulatory submissions and requirements w.r.t to Stability studies.

Interpreting data and adhering to cGMP (FDA and MHRA) guidelines for routine documentation.

Managing Change controls for exhibit department for stability protocols, and testing monographs.

Planning and working collaboratively with cross-functional team of Analysts.

Certified trainer and responsible to perform trainings at site.

Responsible to implement quality system within the QC department.

SOP writing, review, and approval.

Responsible to handle regulatory audits at site QC. 2.2. Glenmark Generics SA, Buenos Aires, Argentina, (Sterile- Oncology: Injectables and OSD): -

Working as Supervisor – Quality Control, duties involved:

During my deputation to Glenmark Argentina I was reporting to Site Quality head for the QC related activities.

Group leader for Stability department.

Overseeing the routine planning for stability analysis, raw materials (API and Excipients) and finished products, Hold time studies, SFI studies and Process Validation studies for Validation and Submission batches.

In charge of ongoing Stability studies and regulatory submissions, stability report preparation/approvals, etc.

In charge of all new oncology projects in the pipeline for Glenmark, Argentina S.A.

Responsible for planning (with R&D) all Method Validations, Verifications, Technology Transfers, SFI studies at Buenos Aires, Pilar site.

Responsible to check and facilitate the discussions for regulatory submissions and requirements w.r.t QC documents.

Interpreting data and adhering to cGMP (FDA and MHRA) guidelines for documentation.

Managing Lab Incidents, Change controls, OOS, OOT and Deviations, etc.

Duration:

Aug (2010)-June (2012)

(Quality and R&D)

Recognitions:

Site representative for Data Integrity

and Compliance.

Planning and working collaboratively with cross-functional team of Analysts.

Preparation, review and approval of STP, Specification, Inspection Plans, TDS, Technology Transfer Protocols, and Validation protocols, Stability Study protocols, SFI Study Protocols, SOP’s etc.

Responsible to handle regulatory audits at plant. 2.3. Glenmark Goa, India (OSD, Semi-solid): -

Working as Executive – Quality Control, duties involved:

Routine planning for qualitative and quantitative analysis of raw materials (API and Excipients) consulting In house specification, USP, Eur Ph., BP and IP.

Routine sampling planning of all raw materials, as per the quality manual or guidelines available, etc.

Analytical Data Review, Compilation, and Release or Rejection of Raw Materials.

Interpreting data and adhering to strict cGMP (FDA and MHRA) guidelines on documentation.

Managing Lab Incidents, Change controls, OOS and Deviations.

Planning and working collaboratively with cross-functional teams of Analysts.

Handling receipt and release of Raw Materials through SAP system wherein analytical data is recorded, and Certificate of analysis is generated through SAP.

Managing in house validation projects for Volumetric Solutions/ Mobile Phase solutions/ Buffers, etc.

Handling proposal of Reduced Testing and annual tracking of material under vendor qualification.

Preparation, review and approval of STP, Specification, Inspection Plans, TDS, Technology Transfer Protocols, SOP’s, etc. 3. Novartis:

3.1. Novartis, Dundee United Kingdom (OSD and Suspensions) Working as Chemist - Quality Control, duties involved:

Performing qualitative and quantitative analysis of finished products, stability samples and raw materials consulting USP, Eur Ph., and BP.

Routine study of range of pharmaceuticals, Cleaning Validation and water samples used for manufacturing.

Using analytical techniques such as HPLC, GC, Headspace GC, UV, MS, IR, FTIR (Spectrophotometry), Dissolution and Titration, etc.

Interpreting data and adhering to cGMP (FDA and MHRA) guidelines on documentation when recording data and reporting scientific results using Chromeleon.

CAPA, Lab investigations OOS and OOE’s and keeping up to date with, health and safety requirements in all aspects of the work undertaken.

Duration:

Mar (2010)-Aug (2010)

Duration:

Jan (2008)-Dec (2008)

Managing projects for Validating and developing methods and templates, writing SOP’s, etc.

Faced two FDA inspections during the tenure at Novartis. 3.2. Novartis Ltd Dundee United Kingdom (OSD, Suspensions, Injectables, etc.): -

Working Analyst / Chemist - R & D unit (Stewardship Analytics), duties involved:

Performing qualitative and quantitative analysis for range of pharmaceutical samples for method validation and development.

Using analytical techniques such as HPLC, GC, Dissolution, etc.

Interpreting data and adhering to cGMP (FDA, MHRA) guidelines on documentation when recording data and reporting scientific results.

Operating dissolution bath to perform content uniformity studies on tablets and capsules for EB and VB.

Writing SOP’s and protocols / reports.

Calibrating equipment and maintaining logbooks.

Implementing CAPA for Quality Assurance and traceability of all the analysis and investigations done.

Member of the Data Integrity team for Novartis- Global Quality. 4. Drug Discovery Unit, University of Dundee, United Kingdom: - Working as Research Associate (Compound Handler- Drug Discovery), duties involved:

Compound Management to very high standards within the laboratory.

Meticulous Routine Management of compounds using automatic liquid handling robotic systems in the screening laboratory for LC- MS and Assay development.

Using Analytical Techniques (like HPLC, GC, LC-MS etc.) for the analysis of raw materials and maintaining high levels of accuracy. Maintaining a detailed report and working on Method validation.

Maintaining GLP, GCP and keeping health and safety issues in mind while working in a highly sensitive environment.

Maintaining data and reporting scientific results.

Quality Check of instruments and calibration of pipettes monthly and maintaining analytical records.

5. Life Business Projects Pv. Ltd: -

Analyst – Quality Control

Working in manufacturing units for different Life sciences projects, duties involved:

Performing qualitative and quantitative analysis on samples from various sources.

PERSONAL INTERESTS

I am very passionate towards football

and cricket. Represented reputed

clubs, school, university, and

company. Played for Percy Mains

Cricket Club, United Kingdom for

seasonal games and Cup games for

county level games.

REFERENCES

Available upon request

Using analytical, biochemical and microbiological techniques such as GC, HPLC, AAS, FTIR, Titrations, Ion chromatography, and spectroscopy (infrared and ultraviolet, amongst others), Fermentation, Gel Electrophoresis and PCR.

Interpreting data and adhering to cGMP, GLP guidelines on documentation when recording data and reporting scientific results.

Performing IR, Assay, Disso, CU, Disintegration tests for routine samples from sponsors.

Working collaboratively in cross-functional teams.

Being aware of and keeping up to date with, health and safety in all aspects of the work undertaken.

OTHER TRAININGS

Gained exposure as trainee at reputed organizations to understand process and systems.

Lean Labs, Six Sigma, Global process harmonization, SAP, Trackwise, Veeva, LIMS, etc projects.

Academic World International: Jan-May (2008) (6 Months Project): Isolation and Identification of lactobacillus, DNA purification and extraction, PCR for DNA amplification, Gel Electrophoresis and construction of dendrogram to see the variation.

Som Distilleries Pv. Ltd: June-July (2007) (trainee- vocational training program): Distillation Plant, Fermentation Plant, Boiler Plant, ETP, Bottling and Packaging.

Bhilai Steel Plant: May -June (2007): Oxygen Plant, Coak Oven, Environmental science department, Industrial Waste Treatment Plant: Wastewater treatment and effluent treatment.

Sanchi: June (2006): Pasteurization process unit, QC, ETP. IT & ANALYTICAL SKILLS

Confident user of all Microsoft office applications, Email, Internet, etc. Gained comprehensive experience on LIMS, Empower3, EDS 365, Custom Fields, Chromeleon, EMS, Minitab and few other complex softwares.

With my previous and current experience, I have worked within Quality Control, R & D, Drug Discovery and on various Life Sciences projects where I have gained knowledge and developed my ability on troubleshooting to provide effective solutions. I have good knowledge of analytical and biochemical processes, regulatory requirements with respect to quality systems, instruments, qualifications. I have experience of working with different pharmaceutical companies and life sciences department where I have gained knowledge of OSD, Sterile-OSD/Injectables (Oncology), Semi-Solid, Suspensions, etc., and the range of analytical / bioanalytical techniques.

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