Rekha Pradeep Nair-CSV / CSA Consultant & Compliance Documentation Lead | GMP, GCP
Check rate
Experience
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.
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.
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.
Research Associate
Sanmar Research Centre (PROCITUS)
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.
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.
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
Education
JJTU
PhD · India
Kerala University
MSC · Organic Chemistry · India
Statistics
Experience
Global experience
Expertise
Qualifications
Profile
Frequently asked questions
Have questions? Find more information here.
Rekha Pradeep is based in Pune, India.
Rekha Pradeep speaks the following languages: English (Advanced), Malayalam (Advanced).
Rekha Pradeep has at least 23 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.
Based on recent experience, Rekha Pradeep would be well-suited for roles such as: Head of Quality, Manager QA, Asst Manager QA.
Rekha Pradeep's most recent position is Head of Quality at Deccan Nutraceuticals Pvt Ltd.
In recent years, Rekha Pradeep has worked for Deccan Nutraceuticals Pvt Ltd.
Rekha Pradeep is most experienced in industries like Pharmaceutical, Chemical, and Manufacturing.
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.
Rekha Pradeep has recently worked in industries like Pharmaceutical.
Rekha Pradeep has recently worked in business areas like Product Development and Quality Assurance.
Rekha Pradeep holds a Doctorate from JJTU and a Master in Organic Chemistry from Kerala University.
The availability of Rekha Pradeep needs to be confirmed.
Daily rate distribution
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Average rates for similar positions
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The average daily rate is the mean of all daily rates from recent contracts of comparable freelancers on our platform.
The median daily rate is the middle value of all daily rates — half of comparable freelancers charge less, half charge more. Unlike the average, it is barely affected by outliers.
Calculated based on our freelancers’ daily rates as of 28 Aug 2026. Actual rates may vary depending on seniority level, experience, skill specialization, project complexity, and engagement length.
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