Chandra Sekhar

(Certified Quality Auditor from American Society for Quality)

Vice President - Quality Assurance at Biological E (Vaccines)

E-mail: adqw9l@r.postjobfree.com Mobile: +91-915******* Address: A 12 I, Jan’s Sri Ram Garden, Suchitra, Secunderabad - 500065 linkedin.com/in/chandra-sekhar-asq-cqa-5b14187

PROFESSIONAL SYNOPSIS

More than 27 years of extensive Data integrity, Quality Assurance, Quality Control, Regulatory, Audits, Pharmacovigilance and hands-on compliance experience in international matrix reporting organizations like Biological E, Reliance Life Sciences, Ranbaxy, United States Pharmacopeia (USP) and Dr. Reddy’s at plant and corporate locations. Expertise in several drug therapeutic categories of Bio-similars, Plasma Proteins, Peptides, Vaccines and Pharmaceuticals.

Expertise in implementation of Quality Systems, Sterility Assurance, Compliance, Risk management, Quality Metrics and cGMP in the Organization as per US, EU and other regulatory bodies.

Excellent leadership during remediation activities and lead most recent US FDA and MHRA successful inspections for Injectable, OSD and API Plants (2019, 2018, 2017, 2016, 2015). Never received warning letters.

Certified Quality Auditor from American Society for Quality (ASQ CQA) and expertise in the Audit data base. Developed training programs based on USFDA warning letters and 483s.

Demonstrated organizational abilities and exposure of regulatory audits like USFDA, MHRA, EDQM, TGA, NPRA, ANVISA, ISO 17025, ISO 9001, WHO, CDSCO, continuous process improvement, End-to-End design and development of e-platforms like LIMS, QAMS (Trackwise), e-BMR, Warehouse Management and Track & Trace Solutions, LMS etc.,

Effective Communication with good management skills, strong trouble shooting. Root Cause Identification, Analytical problem solving and organizational skills.

Good interpersonal relationship, Project management and strong decision making capabilities and act Independence with discretion in routine tasks.

Onsite official visits to Washington D.C, New York, New jersey, Baltimore, Italy and China. Attended to USP’s prescriptions/nonprescription Stake Holder Forums at Rockville, Maryland.

Excellent leadership, People management, intercultural communication and negotiation skills in multi-cultural global matrix reporting environment. Received “Quality Leadership Award” by World Quality Congress and “Lightning Award” at USP.

Received “Leader of the Year” and selected as member of Executive Management Team at Reliance Life Sciences.

ACADEMIC QUALIFICATIONS

Sr.No.

Course

University

Year

Percentage/Grade

1

Certified Quality Auditor

American Society for Quality, USA

2007-08

NA

2

M.Sc (Tech), Pharmaceutical Chemistry

BITS Pilani

2004-07

8.5/10 CGPA

3

PG Diploma in IPR and Patents

NALSAR, Hyderabad

2010-11

B+

4

PG Diploma in Chemical Analysis and Quality management

Central University, Hyderabad

2002-03

B+

5

B.Sc (Chemistry)

Andhra University

1991-94

First

ORGANIZATIONAL EXPERIENCE:

Sr. No

Designation

Company

Duration

Responsibilities

1

Vice President Quality Assurance

Biological E Ltd,

May’20 onwards

Leading the teams of Vaccine QA Operations - IPQA, Fill Finish Sterile Injectables, QMS, Training, Projects (Engineering), Development QA, Validations, Vendor Management, CSV and IT QA; Team size: 120+

2

Vice President and Group Head-Quality Assurance Corporate

Reliance Life Sciences

Dec’18 – May’20

Head of Corporate Quality for Sterilie Injectables- Bio-Similars, Pharma and Plasma Proteins, Developmental QA (DQA), Contract, Third Party Manufacturing, R&D Plants and electronic QMS systems (IT QA), CQC and Pharmacovigilance

3

Vice President –Quality Operations

Reliance Life Sciences

May-14 to December 2018

Head of Operations Quality. Sterile Injectables- QA, QC, DQA, IT QA functions of Injectable and Drug Substance plants, with additional responsibilities of Corporate QA for Biosimilar, Plasma Proteins, Pharmaceuticals, Medical Devices, Cord Blood Repository, Molecular Medicines, Pharmacovigilance, Veterinary QA, Clinical Trials, CQC groups.

4

General Manager

Ranbaxy

Feb’13- May’14

Implementation of Data integrity processes across organization, Office of Data Reliability (ODR), Audits and Compliance for Formulations and API plants

5

Senior Manager

USP

July’11- Jan’13

Monographs and Reference Standards (QC and QA), Audits and compliance for API, Drug Products for Pharmaceuticals and Biologics.

6

Manager

USP

Dec’08-June’11

USP Monograph Development/Quality management /Auditing-API, Drug Products for Pharmaceuticals and Biologics.

7

Senior Scientist

USP

June’08-Nov’08

Group Leader, Quality Control for API, Drug Products for Pharmaceuticals and Biologics.

8

Senior Redesign Conversion Specialist

USP

June’07-May’08

Team Leader, Quality Control for API, Drug Products for Pharmaceuticals and Biologics.

9

Junior Manager, Sr.Executive, Executive, Officer, Supervisor, Chemist

Dr.Reddy’s

Jan’95 to May’07 (12 Years-5 months)

API Plant - Quality Control, R&Ds for Pharmaceuticals

API Corporate Quality Functions for Pharmaceuticals

Experience (starting from the latest)

1.Biological E Ltd., (May 2020 to till date): Heading overall QA Operations, Projects, Development QA (Team Size: 120 plus)

Responsibilities:

1. Ensuring sterile assurance for Blending and Filling facilities. (5 blending suites and 5 filling lines-capacity over a billion dosages per year). Ensuring media fills, aseptic practices, training. Overall Corporate strategy, Planning, Systems Improvement, ensuring team members of Bulk Antigens, Fill Finish Operations, Analytical QA, Training, Validations, Engineering QA (Green field and brown field projects), Development and Commercial Quality Assurance, CSV etc., meets the processes effectively.

2. Identification of trends analyze impact of critical discrepancies. Leading the Vaccine monthly Functional, Operational Review Meetings and quarterly Management Board Review meetings, participating in business planning meetings and providing inputs on prioritization, resource planning and structure redesign formulate Quality strategy based on vaccine business strategy.

3. Training Analyze training needs of employees, quality perspective designing training modules and conduct GCP, GLP, GMP and leadership training for employees across levels and functions, ensuring compliance, vendor qualifications, media fills, aseptic assurance for Fill & Finish, ensuring the product quality and stability.

4. Conducting goal setting, performance appraisals and mentoring coaching for own team members collaborate with HR in manpower planning, recruitment activities, Operational and Capex budget etc.,

5. Quality Systems Harmonization across the business vertical.

6. Conducting audits for internal and external Quality systems.

7. Responsible for handling external audits (regulatory and customers).

Products Handled: COVID-19 vaccine, Diptheria, Tetanus, Hep-B, Pertusis, Hib Conjugate, Japanese Encephalitis, Measures, Rubella, Typhoid conjugate, Pneumococcal Conjugate Vaccine (14 valent), DTwP-HepB-Hib-IPV (Hexavalent), DTwP-Hib Vaccine, Inactivated Poliomyelitis Vaccine, Hepatitis A, nOPV

Key Achievements: Designed Performance Metrics and implemented ~120 Key Performance Indicators and Quality Metrics; Ensuring USFDA Quality Standards across the manufacturing plants; Successful regulatory inspections;

2.Reliance Life Sciences (May 2014 to May 2020): Head-Corporate Quality; Head-Pharma Quality Operations (Vice President), Member of Executive Management Team.

Key Responsibilities:

2.1Ensured sterile assurance for Injectables and other dosage forms. Conducted media fills and ensured aseptic practices through continuous trainings.

2.2Handled Quality functions (QA, QC, DQA, R&D, Microbiology, Computer System Validations) for Life Sciences Division (Bio-Similars, Pharma-Oncology, Plasma, Gene-Therapy, Therapeutic Proteins, Clinical Services, Medical Devices), media fills, aseptic assurance for Fill & Finish,

2.3 Self-Inspections, Training, Building Quality Culture, Validation Master Plan

2.4Implementation of effective Change Controls, Handling Deviations, Stability studies, CAPA and Harmonization of the Quality Systems.

2.5Key Point of Contact and handling Regulatory agencies, customer and vendor audits- US, EU, China, ROW stakeholders.

2.6Handling Complaints and Queries (ANDA, DMF) for all regulated markets

2.7Implementation of LIMS, Trackwise (QAMS), DMS, e-learning modules, e-BMR, Track&Trace, Pharmacovigilance Software

2.8Costing and Budgeting

Key Achievements:

Obtained approvals from following regulatory agencies. Received “Leader of the Year Award”

Promoted as Group Head and member of Executive Management Team of the organization.

Site Name

Type of Products

Inspecting Authority

Year

Renewal or 1st time to the company

Inspection Outcome

Reliance Life Sciences

OSD (Tablets and Capsules)

USFDA

2019

First Time

Successful

Reliance Life Sciences

Sterile Injectables (Oncology) and OSD

MHRA and Turkey MOH

2019

First Time

Successful

Reliance Life Sciences

Biosimilars

INVIMA

2019

First Time

Successful

Reliance Life Sciences

Sterile Injectable (Oncology)

USFDA

2018

First Time

Successful

Reliance Life Sciences

Sterile Injectables (Oncology)

NPRA, Malaysia

2018

First Time

Successful

Reliance Life Sciences

OSD (Tablets and Capsules)

MOH, Kenya

2018

First Time

Successful

Reliance Life Sciences

OSD (Tablets and Capsules)

EMA, Poland

2018

First Time

Successful

Reliance Life Sciences

OSD (Tablets and Capsules)

Turkey MOH

2017

First Time

Successful

Reliance Life Sciences

Sterile, OSD, Plasma, Bio-similars

WHO GMP

2015 -2019

Renewal

Successful

Reliance Life Sciences

OSD (Tablets and Capsules)

MHRA, UK

2017

First Time

Successful

Reliance Life Sciences

OSD (Tablets and Capsules)

FDA, Philippines

2017

First Time

Successful

Reliance Life Sciences

Oncology API

USFDA

2018

Renewal

Successful

Reliance Life Sciences

Oncology API, OSD, Injectable

WHO GMP

2018

Renewal

Successful

Reliance Life Sciences

OSD (Tablets and Capsules)

Ukrainian Medical Council

2017

First Time

Successful

Reliance Life Sciences

Oncology API

USFDA

2015

First Time

Successful

Reliance Life Sciences

Oncology API

COEFPRIS (Mexican)

2015

First Time

Successful

Major Products handled in Reliance: Rituximab, Pegfilgrastim, Tenecteplase, Infliximab, Adalimumab, FSH, Bevacizumab, Albumin, Imunoglobulin, Temozolomide, Capecitabine, Pemetrexed, Bortezomib, Lenalidomide, Terlipressin and several other oncology molecules.

3.Ranbaxy (Feb 2013 to May 2014)): Head-Office of Data Reliability (General Manager);

Key Responsibilities:

3.1Audits and Compliance

3.2Trainings & Building Quality Culture

3.3Performing Data Integrity Audits

3.4Electronic Systems (Trackwise & electronic Training Modules & 21 CFR compliant Data Management Systems-Laserfische)

3.5Implementation of effective change Controls, Deviation, CAPA, Stability Data, Audit Management

Key Achievements:

Set-up India’s first Office of Data Reliability (ODR) Department at Ranbaxy

Built Strong Quality Culture through rigorous gap assessments & trainings

Major Products Handled: More than 100 products (OSD & API) on several therapeutic categories

4.United States Pharmacopeia –USP (June 2007 to Feb 2013); Senior Manager

Key Responsibilities:

4.1QA and QC functions

4.2Trainings and self-inspections

4.3Ensuring 21 CFR Compliance

4.4 Implementation of effective change Controls, Deviation, CAPA and Audit Management

4.5Handling Expert Committees and Expert Panels

4.6Monograph Redesign

4.7Interaction with stakeholders, regulators, industry and academia subject matter experts

4.8Development and redesign of Pharmacopeia monographs and Development of Reference Standards

Key Achievements:

Received Lightning Award

Worked with multi-cultural matrix reporting global organization. Interacted with US, EU, China regulators, industry stake holders.

Major Products Handled: More than 100 monographs on several therapeutic categories for Pharma and Bio-Pharma molecules.

5.Dr.Reddy’s (Jan 1995 to June 2007);

Last designation: Junior Manager

Key Responsibilities:

5.1Corporate Quality and plant QC functions

5.2Implementation of GLPs, suitable analytical HPLC and GC methods for various APIs in QC.

5.3Stability programs for the APIs and holding time studies for intermediates and key raw materials.

5.4 Planning and implementation of cGMP/GLP in the QC and Microbiology laboratories

5.5Interaction with stakeholders, regulators

5.6Review and approval of analytical method development reports and formulating the test specifications for APIs, intermediates and raw materials and coordinating method transfers to QC Lab

5.7Exposure to many analytical techniques such as HPLC, GC, Particle size analyzer, XRD, TGA, DSC, HPTLC etc.,

5.8Investigation for the OOS results and implementing the preventive and corrective measures. Quality Trend

5.9IQ.OQ.PQ for all the equipment of quality control Laboratory and preparation of standard test

procedures, standard operating procedures and analysis work books.

5.10Harmonization of CORE SOPs

5.11Review and approval of all Standard Operating Procedures, stability, all types of validation

protocols and reports and other quality related documents.

5.12 Coordination with RA for preparation and submissions of regulatory submissions.

5.13 Vendor Qualifications/Performance

5.14Updates with the current trends in the pharmaceutical industry, regulatory guidelines such as

USFDA, ICH and Pharmacoepias like USP, EP, JP and IP.

5.15Investigations, CAPA, Process, method and System Audits.

5.16Training of Employees on GMP, 21-CFR, ICH-Q7, Quality by Design guidelines.

5.17Key team player in the SAP implementation, my DREEM (Dr.Reddy’s Execution Excellence

Model) project for analytical cycle time reduction and optimization of the QMS systems.

5.18Handled more than 100 molecules with several therapeutic categories during the 12.5 years of

Dr.Reddy’s career.

5. Skills

1. Training, motivating and mentoring team members to work in synchronization with corporate objectives.

2. Driving team efforts to accomplish the targets to achieve the organizational goals.

Strong trouble shooting and Root Cause Identification

Analytical problem solving and organizational skills.

Effective Communication with good management skills

Good interpersonal relationship and Project management

5. Significant Accomplishments/Awards:

Received “Quality Leadership Award ” by World Quality Congress.

“LIGHTNING AWARD” at United States Pharmacopeia.

Visited USP Head Quarters, Washington D.C, Italy and China

Visited Covidien (Mallinckrodt Baker) Head Quarters, New Jersey, USA.

“Appreciation letter and Cash Award” at United States Pharmacopeia

Received appreciation Certificate for “Speedy and prompt response” to customers at Dr.Reddy’s

6. Professional affiliation:

Certified Quality Auditor from American Society for Quality (USA).

Alumni of prestigious universities-BITS Pilani, National Law University and Central University.

Expert Committee Organizer in the United States Pharmacopeia

Expert Speaker, Panel members, Expert Committee member during the conferences organized by Waters, CPhI, Select Bio, UBS, Explore Exhibitions, Dassault Systems, Department of IT (Government of Karnataka), Messe Frankfurt, Virtue Insight, IMAPAC (Singapore), ACG, SciTech, Bio-Trains, UBM, UBS forums on Risk Assessments, Compliance, Data Integrity, Quality by Design etc.,

7. Other Accomplishments:

Core team member of USP Advisory Panel in the implementation of Standard Setting Process

Core team member of USP Expert Committee for Medicines Compendium.

Internal Quality Auditor for Quality Management Functions.

Committee member for Management Review Meets

Core Team member for quality module for SAP implementation in the Organization.

Core Team member in the New Product Development (NPD)

LEARNING AND CONTRIBUTIONS

Presentations on Monograph Development process made at several Companies which includes Dr.Reddy’s, Aurobindo, Glenmark, Sun Pharma, Cipla, Matrix Laboratories, CadilaPharma, Fresenius-Kabi, Jubilant, Orchid etc.,

Actively involved in the USP Annual Scientific Meetings/Scientific and standards Symposium

• Participated as in 21st Expert Committee face to face meetings.

• Actively participated in Indian Pharmacopeia- USP (IPC-USP) Advisory Panel meetings (face to face and telecons)

• Received training on “Laboratory Management as per ISO/IEC-17025:2005 by STQC

• Attended IPA-EDQM-IPC Technical two days conference

• Attended DIA “CTD Dossier Requirements”

• Attended ISPE-2 days “PQLI & QMS-New Avenues, New Milestone”, USP Pharmacopeial Education courses like “Validation & Verification of Compendial Procedures”, “cGMP: A Quality Systems Approach for APIs”, “Bacterial Endotoxin Testing”, “Effectively Using Reference Standards”, “Good Pharmaceutical Packaging Practices”

• Trained on ISO 9001:2008 from BSi

• Trained on Basic Life Support & First Aid Skills, Basic Fire Safety and Emergency preparedness during from External Safety Consultants.

• Attended Liquid Chromatography by Waters.

• Regular participation in training programs related to Stability studies, Regulatory requirements, new product development, interpersonal soft skills, cGMP for API, ICH guidelines, EDQM etc.,

• Attended various courses like Technical Conclaves, HPLC, GC, Quality control, ISO, TQM, Quality Approach, Team Leadership, Time Management, Report Writing Life Skills etc,

Implemented 5S/KAIZEN, Analytical Cycle time reduction etc.,

Personal Profile

Name : Satya Chandra Sekhar N Date of Birth: 16-07-1974

Fathers Name : Late Satyanarayana (M.Sc. B.Ed- Teacher)

Marital Status: Married and have two children (Son- B.Tech Computer Science Engineering; Daughter-11th Standard)

Nationality: Indian; Permanent Address :D.No. 8-24-22, Gandhinagar, Kakinada, East Godavari District, AP, India-533004

Declaration

I do hereby declare that all the above-furnished information is true to my best knowledge.

Hyderabad N . Chandra Sekhar

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