Rekha Pradeep Nair - CSV / CSA Consultant & Compliance Documentation Lead | GMP, GCP

Pune, India

Experience

Aug 2019 - Present

6 years 6 months

Pune, India

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

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

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

Jan 2001 - Dec 2004

4 years

Mangaluru, India

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.

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.

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