Rekha Pradeep Nair - CSV / CSA Consultant & Compliance Documentation Lead

Q: Where is Rekha Pradeep based?

Rekha Pradeep is based in Pune, India .

Q: What languages does Rekha Pradeep speak?

Rekha Pradeep speaks the following languages: English (Advanced), Malayalam (Advanced) .

Q: How many years of experience does Rekha Pradeep have?

Rekha Pradeep has at least 22 years of experience. During this time, Rekha Pradeep has worked in at least 5 different roles and for 5 different companies . The average length of individual experience is 5 years and 6 months . Note that Rekha Pradeep may not have shared all experience and actually has more experience.

Q: What is Rekha Pradeep's latest experience?

Rekha Pradeep's most recent position is Head of Quality at Deccan Nutraceuticals Pvt Ltd .

Q: What companies has Rekha Pradeep worked for in recent years?

In recent years, Rekha Pradeep has worked for Deccan Nutraceuticals Pvt Ltd .

Q: Which industries is Rekha Pradeep most experienced in?

Rekha Pradeep is most experienced in industries like Pharmaceutical , Chemical , and Manufacturing .

Q: Which business areas is Rekha Pradeep most experienced in?

Rekha Pradeep is most experienced in business areas like Quality Assurance , Product Development , and Research and Development . Rekha Pradeep also has some experience in Operations .

Q: Which industries has Rekha Pradeep worked in recently?

Rekha Pradeep has recently worked in industries like Pharmaceutical .

Q: Which business areas has Rekha Pradeep worked in recently?

Rekha Pradeep has recently worked in business areas like Product Development and Quality Assurance .

Recommended expert

Pune, India

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Experience

Aug 2019 - Present

7 years

Pune, India

Head of Quality

Deccan Nutraceuticals Pvt Ltd

Spearheaded Quality Assurance and Control processes at Deccan Nutraceuticals since 2019, ensuring strict regulatory compliance.
Managed API industry queries effectively, leading to prompt resolution and enhanced customer satisfaction.
Championed new product development initiatives, achieving USFDA and EDQM compliance in 2023 and 2022 without any observations.
Fostered a high-performance work environment, resulting in remarkable organizational success and employee engagement.
Implemented robust computer system validation processes, ensuring reliability and adherence to compliance standards.
Conducted comprehensive SOP training for team members, enhancing procedural adherence and operational efficiency.

Jan 2018 - Dec 2019

2 years

Pune, India

Manager QA

Aanjaneya Health Care

Managed Formulation QA team for one year at Aanjaneya Health Care, ensuring compliance with quality standards.
Developed and implemented quality assurance protocols to enhance product reliability.
Conducted in-depth audits and assessments to identify areas for process improvement.
Trained team members on QA best practices to elevate overall departmental performance.
Collaborated with cross-functional teams to integrate quality measures into product development.
Analyzed quality data and generated reports for management review, facilitating informed decision-making.
Led root cause analysis initiatives to address quality deviations and implement corrective actions.
Spearheaded initiatives that resulted in a 20% reduction in quality-related incidents.
Championed a culture of continuous improvement by promoting proactive quality measures.
Engaged in knowledge-sharing sessions, enhancing team competencies in quality assurance.

Jan 2011 - Aug 2019

8 years 8 months

Pune, India

Asst Manager QA

Emcure Pharmaceuticals

Managed quality assurance processes, enhancing compliance with regulatory standards.
Contributed to organizational success through the implementation of effective QA strategies.
Played a key role in ensuring adherence to quality standards across all levels.
Served as an analytical reviewer, demonstrating expertise in Quality Management Systems (QMS).
Handled investigations and customer complaints with high precision and accuracy.
Demonstrated proficiency in analytical skills, leading to improved assessments and decision-making.
Executed Computer System Validation, ensuring system compatibility and functionality.
Streamlined QA processes, contributing to improved overall operational efficiency.
Trained team members on best practices in quality assurance and compliance.
Leveraged analytical insights to drive strategic improvements in QA protocols.

Jan 2004 - Dec 2007

4 years

Chennai, India

Research Associate

Sanmar Research Centre (PROCITUS)

Jan 2001 - Dec 2004

4 years

Mangaluru, India

QC Officer

Strides Arcolab Ltd

Ensured product quality and compliance as a QC Officer at Strides Arcolab Ltd. for 4 years.
Conducted rigorous testing protocols to maintain high standards in pharmaceutical production.
Collaborated with cross-functional teams to implement quality improvement initiatives.
Identified and resolved quality issues to enhance operational efficiency by 15%.
Trained and mentored junior staff on best QC practices and procedures.
Developed and maintained comprehensive documentation to support regulatory compliance.
Analyzed data and trends to recommend actionable adjustments in manufacturing processes.
Utilized advanced analytical techniques (HPLC, GC, etc.) for precise quality assessments.
Achieved a reduction in product complaints by 20% through diligent monitoring.
Liaised with external regulatory bodies to ensure adherence to industry standards.

Industry Experience

See where this freelancer has spent most of their professional time.

Experienced in Pharmaceutical, Chemical, and Manufacturing.

Pharmaceutical

Chemical

Manufacturing

Business Area Experience

See which departments and functions this freelancer has contributed to most.

Experienced in Quality Assurance, Product Development, Research and Development, and Operations.

Quality Assurance

Product Development

Research and Development

Operations

Summary

Proven track record in Quality Management, ensuring adherence to regulatory standards and industry best practices.
Developed customised solutions to successfully address complex regulatory challenges.
Conducted thorough audits that facilitated the development and commercialisation of new products.
Enhanced customer satisfaction by maintaining the highest quality standards and reducing errors.
Championed a culture of quality and excellence within teams and projects.
Emphasised continuous improvement practices to optimise processes and compliance.
Leveraged analytical skills to identify and resolve quality-related issues effectively.
Collaborated across departments to align product development with regulatory requirements.
Maintained a rigorous attention to detail, ensuring comprehensive documentation and reporting.

Skills

Quality Assurance
Management
Pharmaceuticals
Leadership
Communication
Quality Management
Computer System Validation
Cross-Functional Collaboration
Quality Management Systems (Qms) Auditing
Regulatory Affairs
Data Integrity
Regulatory Compliance
Management Systems
Quality Control
Quality Management Systems
Strong Communication
Investigator

Computer System Validation

Computer System Validation: Extensive Experience In The Validation Of Computer Systems, Including Cloud-Based And Network Systems, Ensuring Robust Performance And Compliance With Regulatory Standards.
Pharmaceutical Laboratory Systems: Proficient In Validating All Pharmaceutical Laboratory Systems, Ensuring They Meet Rigorous Industry Standards And Regulatory Requirements.
Clinical Data Management Systems: Demonstrated Expertise In Validating Clinical Data Management Systems, Ensuring Adherence To 21 Cfr, Annex 11, And Hipaa Regulations.
Regulatory Compliance: Strong Background In Ensuring Compliance With Us And Eu Regulations, Including 21 Cfr And Euralex Standards, Maintaining The Highest Level Of Data Integrity And Security.

Audit Experience

Throughout My Career, I Have Successfully Faced Audits From Regulatory Bodies Such As Usfda, Edqm, Mhra, Anvisa, Who, Iso 9000:2008, 14001:2004, Cdsco, Mhfda, Along With Routine Customer Audits From Prominent Organizations Such As Novartis, Abbott, Solvey, Glaxosmithkline, Bayer, Banfroad Chemicals, Bristol Mayer Squibb, Ciba, Laurus, Sanofi, And More.
I Have Actively Performed Vendor Audits Of Contract Laboratories And Raw Material Suppliers, Contributing To The Overall Quality Assurance Processes.

Areas Of Interest

Quality Assurance And Quality Control
Regulatory Affairs
Intellectual Property Rights

Languages

English

Advanced

Malayalam

Advanced

Education

JJTU

PhD · India

Kerala University

MSC · Organic Chemistry · India

Statistics

Experience

Total positions 5

Experience in Pharmaceutical 19.5 y

Avg length 5 y 1 m

Longest experience 8 y 7 m

Global Experience

Countries worked in 1 (India)

Primary country India

Expertise

Recent roles Head of Quality, Manager QA, Asst Manager QA

Main industries Pharmaceutical, Chemical, Manufacturing

Main business areas Quality Assurance, Product Development, Research and Development

Qualifications

Highest degree Doctorate

Profile

Created

January 2026

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Frequently asked questions

Have questions? Find more information here.

Where is Rekha Pradeep based?

Rekha Pradeep is based in Pune, India.

What languages does Rekha Pradeep speak?

Rekha Pradeep speaks the following languages: English (Advanced), Malayalam (Advanced).

How many years of experience does Rekha Pradeep have?

Rekha Pradeep has at least 22 years of experience. During this time, Rekha Pradeep has worked in at least 5 different roles and for 5 different companies. The average length of individual experience is 5 years and 6 months. Note that Rekha Pradeep may not have shared all experience and actually has more experience.

What roles would Rekha Pradeep be best suited for?

Based on recent experience, Rekha Pradeep would be well-suited for roles such as: Head of Quality, Manager QA, Asst Manager QA.

What is Rekha Pradeep's latest experience?

Rekha Pradeep's most recent position is Head of Quality at Deccan Nutraceuticals Pvt Ltd.

What companies has Rekha Pradeep worked for in recent years?

In recent years, Rekha Pradeep has worked for Deccan Nutraceuticals Pvt Ltd.

Which industries is Rekha Pradeep most experienced in?

Rekha Pradeep is most experienced in industries like Pharmaceutical, Chemical, and Manufacturing.

Which business areas is Rekha Pradeep most experienced in?

Rekha Pradeep is most experienced in business areas like Quality Assurance, Product Development, and Research and Development. Rekha Pradeep also has some experience in Operations.

Which industries has Rekha Pradeep worked in recently?

Rekha Pradeep has recently worked in industries like Pharmaceutical.

Which business areas has Rekha Pradeep worked in recently?

Rekha Pradeep has recently worked in business areas like Product Development and Quality Assurance.

What is Rekha Pradeep's education?

Rekha Pradeep holds a Doctorate from JJTU and a Master in Organic Chemistry from Kerala University.

What is the availability of Rekha Pradeep?

Rekha Pradeep is immediately available for suitable projects.

What is the rate of Rekha Pradeep?

Rekha Pradeep's rate depends on the specific project requirements. Please use the Meet button on the profile to schedule a meeting and discuss the details.