Janita Vallabh

• Conducted complex investigations using scientific root cause analysis, ensuring compliance with GMP and ISO requirements.
• Worked closely with team members to achieve specific project goals and deadlines.
• Identified issues, analysed data, and implemented effective solutions to enhance operational processes.
• Owned inspection-ready documentation management in Veeva for CAPAs, deviations, and audit records.

Listed key achievements in role

• Directed corrective and preventive actions that reduced invalid investigations by 20 % annually.
• over the 5 year implementation period led to a reduction from 356 analyst errors investigations to under 100 analyst errors monitored bi-annually.

• Serve as Subject Matter Expert (SME) for analytical method validation, verification and transfer.
• Author and approve method development and validation protocols and reports, standard operating (SOP) documentation ensuring current practices.
• Review and evaluate dossier and pharmacopoeial methods (USP, EP, JP and Chinese Pharmacopoeia) to ensure regulatory and compliance oversight.
• Identified analytical gaps and risks in equipment and testing against laboratory practices to facilitate seamless transfer and implementation.
• Lead cross functional team in assessing what equipment is required a risk-based approach to establish how routine testing can be streamlined and optimized for routine testing.
• Complete user specification (URS) for new analytical equipment as well as an evaluation if equipment is fit for purpose meeting validation requirements (IQ; OQ and PQ). Ensuring right first time.
• Strategic Planning and Project Management to ensure projects and validation milestones are achieved and communicated.
• Develop laboratory testing strategies and retention sample programmes for transition from development to commercialisation.
• Spearheaded innovative strategies to streamline project delivery, resulting in improved operational efficiency.
• Led cross-functional initiatives that enhanced laboratory efficiency and standardised analytical practices.
• Led cross-functional teams in high-stakes environments, fostering collaboration and driving successful outcomes.
• Mentor analysts and deliver technical training on new analytical technologies and laboratory procedures through SOP and practical training enforcement.

Provided key project highlights to stakeholders.

• Represented the Small Volume Parenteral Site at an International level for the Harmonization of Biological potency assay using robotic liquid handlers.
• Presented at workshops and seminars on specialist subjects, establishing thought leadership and promoting best practices.
• Presented findings and strategies to stakeholders, ensuring alignment with organisational goals and objectives.

• Reviewed stability data to identify root causes of stability failures using risk assessments, fishbone diagrams, and 5 whys analysis.
• The stability out of specification ( product failure) alert process was improved from a paper-based to an electronic process within the quality management system (QMS). This ensured regulatory compliance and prompt corrective action and audit readiness.
• Managed OOS notifications and ensured timeous communication to internal stakeholders and customers within 24 hours.
• Prepared scientific stability reports to facilitate product registration and meet customer requirements.
• Executed project schedules by planning and coordinating timelines to ensure on-time delivery.

• Developed, validated, and transferred analytical methods for pharmaceutical products using HPLC, UV spectrophotometry, dissolution, infrared spectroscopy, particle size analysis, and titrimetric analysis to ensure product quality and regulatory compliance.
• Performed compatibility assessments (active-excipient), forced degradation testing, and stability studies, along with non-routine analytical investigations to support product development and regulatory submissions.
• Resolved complex chromatographic issues through scientific troubleshooting.
• Conducted laboratory quality reviews ensuring GMP and data integrity compliance (ALCOA) improving compliance and inspection readiness.
• Mentored junior analysts, fostering a culture of compliance and continuous improvement to enhance laboratory performance and uphold quality standards.

• Produced analytical data to advance formulation development and assist in regulatory submissions.
• Facilitated pharmaceutical product development through analytical testing and method optimisation, ensuring compliance with GLP, GMP, and ISO 9001 standards.
• Assisted in validation processes to uphold compliance and ensure data reliability.

• Assisted in method development, conducted sample analysis, and prepared scientific reports to ensure accurate data interpretation.
• Conducted analytical testing of raw materials, finished products, and stability samples to support research and development projects.
• Ensured compliance with GMP and ISO requirements by maintaining precise laboratory documentation.

• Acquired practical experience in pharmaceutical analytical chemistry within GMP and ISO-regulated laboratories, enhancing compliance and quality of testing processes.
• Supported senior analysts in analytical testing and method development, contributing to thorough laboratory documentation for successful product development initiatives.
• Worked closely with team members to complete projects effectively.