Gayatri Rajaram
Coventry,West Midlands
Summary
Dedicated professional with over five years of experience in regulatory compliance, quality assurance, and cross-functional collaboration within the healthcare and pharmaceutical industries. Skilled in preparing regulatory documentation, managing compliance with international standards, and driving quality initiatives. Demonstrated expertise in managing Quality Management Systems (QMS) and liaising with global stakeholders to ensure timely and compliant regulatory submissions.
Overview
7
7
years of professional experience
4
4
years of post-secondary education
Work history
Business Process Lead (BPO3)
Tata Consultancy Services
Mumbai, India
04.2023 - 10.2023
- Directed regulatory data system management and documentation control to ensure submission compliance.
- Authored and reviewed SOPs, change controls, and deviations, enhancing document quality for CMC sections.
- Led cross-functional teams in optimizing processes and maintaining GMP standards.
- Oversaw pharmacovigilance and medical writing projects, delivering accurate and regulatory-compliant documents.
- Managed quality assurance processes, including root cause analysis, CAPA management, and compliance tracking.
- Coordinated with cross-functional teams to address quality deviations, ensuring operational adherence to GMP requirements.
- Facilitated team engagement and training sessions on regulatory compliance and operational standards.
- Supported quality audits and inspection readiness by maintaining accurate documentation and regulatory compliance records.
- Directed team activities to ensure compliance with GMP and company SOPs, achieving key operational objectives.
- Oversaw reconciliation and validation processes, ensuring adherence to regulatory standards.
- Provided leadership and support for maintaining Quality Management Systems (QMS), with a focus on efficiency and compliance.
- Conducted team training and performance reviews, fostering professional growth and alignment with operational goals.
- Provided support for maintaining compliance with regulatory requirements, including Good Manufacturing Practices (GMP) and GDP.
- Managed reconciliation and validation processes to ensure timely and accurate reporting of data.
Senior Drug Safety Associate
Qinecsa Solutions
Mysore, India
10.2021 - 11.2022
- Conducted regulatory document reviews, ensuring compliance with international guidelines.
- Managed CAPA processes and executed quality improvement initiatives to align with global standards.
- Supported pharmacovigilance compliance by maintaining accurate regulatory databases.
- Collaborated with regulatory authorities and cross-functional teams to manage safety reporting and regulatory submissions in compliance with GDP requirements.
- Conducted team huddles and trainings to ensure procedural consistency and compliance with quality standards.
- Conducted root cause analysis and implemented CAPAs for non-compliance issues.
- Conducted SOP reviews and participated in Argus validation (UAT), maintaining accuracy in mandatory fields from case booking to submission.
- Engaged in CAPA management, ensuring cases were reviewed and processed with 100% accuracy while adhering to established timelines.
- Updated and maintained safety and regulatory databases, ensuring accurate and up-to-date records.
- Supported CAPA management by identifying root causes and tracking corrective actions through completion.
- Supported implementation and validation of pharmacovigilance software systems (Argus, ArisG).
Clinical Research Associate
Inventurus Knowledge Solutions
Mumbai, India
09.2017 - 09.2021
- Developed clinical study protocols and regulatory submission documents, including IBs and CTAs.
- Maintained QMS documentation to ensure audit-readiness and regulatory compliance.
- Liaised with cross-functional teams to support pre-market approval processes and quality assurance efforts.
- Managed and monitored quality documentation to maintain inspection readiness and regulatory compliance.
- Maintained updated training records, supporting a state of inspection readiness and compliance.
- Managed pharmacovigilance reporting activities, overseeing quality assurance of adverse event reports and supporting PSMF updates.
- Assured training records were updated, supporting inspection readiness and maintaining compliance with SOPs and QMS standards.
- Developed clinical study protocols, case reports, and investigator brochures.
- Implemented EHR systems for efficient clinical documentation, focusing on compliance with safety and regulatory requirements.
Drug Safety Associate
Cognizant Technology Solutions
Mumbai, India
07.2016 - 07.2017
- Processed regulatory submissions, ensuring accuracy and adherence to global standards.
- Conducted quality checks and supported regulatory documentation reviews for clinical trial cases.
- Collaborated with regulatory teams to ensure adherence to global safety requirements, including MedDRA coding and LLT reporting.
- Assisted with audit preparations by organizing and categorizing documents in accordance with established guidelines.
- Supported internal and external audits by ensuring that regulatory documentation and training records were up to date and compliant.
- Facilitated communication with regulatory agencies and cross-functional teams to support submissions and resolve queries.
- Processed and reviewed spontaneous and clinical trial cases, ensuring regulatory compliance and accurate coding using MedDRA and WHODD.
- Responsible for reviewing and processing safety data in line with FDA and EMA regulations.
- Ensured accuracy and regulatory compliance of safety data before submission to regulatory authorities.
- Updated training records and ensured adherence to inspection readiness.
Education
Bachelors Of Pharmacy - Pharmacy
Mumbai
India 01.2012 - 01.2016
Skills
- GMP & ISO Standards: Expertise in maintaining compliance with pharmaceutical quality standards and managing deviations
- Leadership & Development: Proven ability to recruit, train, and motivate high-performing teams
- Quality Assurance: Skilled in implementing and maintaining Quality Management Systems (QMS)
- Operations Management: Experience in setting operational objectives and achieving key performance indicators
- Regulatory Compliance: Strong knowledge of cGMP, Health and Safety standards, and HR policies
- Stakeholder Collaboration: Adept at working with cross-functional teams to achieve strategic goals
Timeline
Business Process Lead (BPO3)
Tata Consultancy Services
04.2023 - 10.2023
Senior Drug Safety Associate
Qinecsa Solutions
10.2021 - 11.2022
Clinical Research Associate
Inventurus Knowledge Solutions
09.2017 - 09.2021
Drug Safety Associate
Cognizant Technology Solutions
07.2016 - 07.2017
Bachelors Of Pharmacy - Pharmacy
Mumbai
01.2012 - 01.2016
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