Pavithra V Email & Phone Number

San Diego, Ca, Us

San Diego, California, United States

• Review and approval of change controls, deviations, CAPA, NCMR, OOS, review batch records, analytical test records and facilitate clinical/commercial product release.• Responsible for co-hosting customer audits and conducting internal auditing.• Develop Quality Metrics on Power BI and excel spread sheets for trending quality system data, EM, Utilities, Equipment C&PM data etc. for Quality Management review. • Review QMS SOPs for compliance with cGMP practices and regulatory requirements including continuous improvements.• Ensure timely closure of QMS documentation, by coordinating with cross-functional teams and driving the resolution process. Compile QMS data and prepare comprehensive reports for quality management reviews, highlighting key findings and recommendations.• Performing Annual Product Quality review and reviewing batch records, analytical testing reports, and validations.

San Diego County, California, United States

• Led the development of MBR templates and provided training to authors on their usage, resulting in improved efficiency of the review and approval process.• Worked on Kaizen continuous improvement projects and developed streamlined workflows on MasterControl for various quality assurance manufacturing support processes and product release.• Reviewed and approved deviations performed impact assessments on change controls, and conducted risk assessments.• Demonstrated leadership within the QA-MFG team by proactively identifying and resolving barriers to day-to-day activities, effectively optimizing operational efficiency and productivity.

San Diego County, California, United States

• Provided support for manufacturing and quality testing, including overseeing processes, reviewing batch records, conducting line clearances, verifying equipment cleaning, and reviewing QC testing, cleaning, and method validation data.• Creating and reviewing clinical labels for finished drug products, ensuring compliance with regulatory guidelines.• Review vendor/supplier/manufacturer/contractor qualification documentation and assisted in Supplier Qualification Programs.• Collaborated in resolving client and regulatory audit findings.• Supported systems to ensure cGMP compliance in all relevant operations at BioDuro, LLC.

San Diego, California

• Developed HVAC and cleanroom validation protocols in collaboration with the validation team, resulting in the successful release of the manufacturing suite and implemented EM program.• Created policies and procedures for media simulation, operator qualification, and gowning based on standards and regulations.• Performed line clearance and approved labels for cell therapy product manufacturing.• Review and approved master batch records and reviewed executed batch records and performed product releases.• Oversaw QMS documentation, including deviation investigations, change control assessments, and corrective actions.• Assisted in audit preparations and provided insights for responding to audit observations.• Reviewed and release of raw materials based on testing as per approved specifications.

Bangalore India

Key Deliverables:• Manage Customer relationship management team and ensure service delivery to annectos customers and prospects is of excellent quality• Ensure the team has the requisite skills and tools to perform their responsibilities efficiently.• Oversee the development of relationship between the CRM and customers also ensure the follow-up schedules and deadlines are met• Workup with marketing team to ensure that marketing campaigns are turned into effective operational delivery; including additional briefing and training for team members as required. • Data analysis of the progress and effectiveness of the program, present program close out meeting with the client. Additional Skills, Knowledge and Abilities• Effective communication, Inspire and motivate team, Maintain integrity and honesty, conflict management.

Mangalore

• Developed a potential Biosimilar MAB used to treat Breast Cancer in lab scale, designed experiments from Plasmid DNA transfections to clonal selections.• Worked upon high efficiency mammalian transfections through scientific journals and patent search.• Analyzed protein concentration by spectrophotometry and SDS-PAGE, protein purification by affinity chromatography & SEC chromatography, managed TFF for high volumes of proteins.• Designed and created in-house ELISA plates for quantitative analysis of proteins, obtained high yielding recombinant proteins, stably transfected cells and cell line expansion.• Worked upon Plasmid DNA extraction, purification, qualification and ligation experiments. Also handled bacterial cultures.• Ensured the research is conducted in accordance with good practice and in compliance with local policies and legal requirements.Additional Skills, Knowledge and Abilities• Successfully produce one batch of lab scale monoclonal antibodies with assistance of 3 members • The protein produced was further utilized for Crystallization experiments and toxicology studies• Lead the project with the team of 4; additional responsibilities of planning, design experiments, procurement, training and presentation were executed.

Bengaluru Area, India

• With the team Biologics pilot plant, Quality Assurance; reviewed manufacturing activities as per ICH guidelines. Audited warehouse and manufacturing facility regularly.• Assisted in maintaining cGMP compliance throughout the facility and follow up for CAPA on the identified non-compliance.• Reviewed investigations of deviations and review of processes and procedures using risk assessment tools like FMEA as a part of Risk assessment team. • Managed approved vendor list, change controls, deviations and CAPAs by maintaining trackers and closure follow-up. Issuance of line clearances and online process monitoring, which ensured product compliance with cGMP.• Review of Master and Executed BMR’s, PDR’s, Technology transfer documents, SOPs and other quality related documents. Also executed quality operations on SAP.• Assisted in vendor qualification, review of vendor approval questionnaire and update approved vendor list. • Effective team player in handling Regulatory audits, Client audits. Handled client quires regarding the executed batch processes efficiently.Additional Skills, Knowledge and Abilities• Observed the operations of bioreactor, fermenter, chromatography systems, TFF • Experienced the Biologics manufacturing and facility maintenance through Grade D to Grade B suite. • Developed planning and organization; communication, reasoning and teamwork skills

Leicester, United Kingdom

• Research project on Developing a cellular model of malignant mesothelioma for Translational studies• Project focus on examining the involvement of the inflammatory cells in maintaining the tumour progression by altering the cellular signaling of the normal cellsAdditional Skills, Knowledge and Abilities• Skills developed on protein extraction and quantification from mammalian cells, cell signaling studies, western blotting, cell growth progression studies, cellomics, co-culture experiments, Mass spectrometry and mammalian cell culture • Findings resulted in further studies on activated macrophages effects, transcriptional profiling, micro-RNA profiling, and translational profiling to identify pathways involved in the development of the disease.• Developed critical thinking, result analysis, designing and reporting skills

• Team Small molecules analytics, Quality control; trained on Testing and release of Small molecules finished product and intermediates, technology transfer from R&D to QC, method transfer and stability activities, following cGMP in manufacturing facility and laboratory • Handled OOS reporting and failure investigations, Change control reporting and CAPA implementation, vendor qualification.• Calibrated lab equipment and assisted with maintaining equipment in department.• Preparation of specifications by referring to Pharmacopoeias (USP, IP, Ph.EUR, JP)• Assisted in responding to technical quires from customers pertaining to quality analysis.Additional Skills, Knowledge and Abilities• Trained on operations of HPLC, GC, IR spectrometry, Potentiometer and Polarimeter equipment• Developed detailed recording, time management, operation monitoring in a cGMP laboratory

Master Of Science (Msc), Cancer Cell And Molecular Biology, Merit

Bachelor Of Engineering (B.E.), Biotechnology

Pre University, Physics, Chemistry, Mathematics, Biology

Sslc, High School/Secondary Diplomas And Certificates