Dr. R. Swathi
BENGALURU,KARNATAKA
Summary
Experienced Pharmaceutical Professional | Regulatory | Product Lifecycle Management | Knowledge Management | Technology Transfer | PMP Certified Results-driven professional with over 8 years of experience in the pharmaceutical industry, specializing in Technology Transfer, Regulatory Product Lifecycle Management (PLM), Knowledge Management and Process Optimization. Proven ability to lead strategic initiatives, foster cross-functional stakeholder collaboration, and deliver high-impact projects aligned with organizational goals. Skilled in identifying opportunities for continuous improvement and implementing scalable, compliant processes. Project Management Professional (PMP) with a strong track record of managing complex, global projects from conception through execution.
Overview
11
11
years of professional experience
1
1
Certification
Work History
Associate - MSAT
Pfizer Healthcare India Pvt Ltd
VISAKHAPATNAM
08.2020 - 12.2022
- Implemented New Product Introduction (NPI) for OEB Class 4 & 5 at Manufacturing Site
- Migrated 05 products (Propofol, Heparin, Lidocaine, Furosemide, SWFI) from test environment to production environment in short time.
- Involved in Life Cycle Management projects
- Involved in Continuous Improvement projects
- Technology Transfer of Sterile Injectables – Successful product transfer with minimized risk and enhanced process efficiency.
- Process Robustness Enhancement – Implemented data-driven strategies to improve batch yield and reduce process deviations.
- Support site inspection readiness program in providing update on commitment tracking action items to leadership team and quality assurance
- CQA & CPP Management – Oversee Critical Quality Attributes (CQA) and Critical Process Parameters (CPP) to ensure process consistency during transfers.
- Technology Transfer (TT)- Facilitate smooth process transfer from R&D to Manufacturing or from one site to another.
- Develop TT protocols, risk assessments, and process validation plans.
- Identify gaps, deviations, and troubleshooting strategies for successful transfer.
- Cross-functional Collaboration – Worked with Regulatory Affairs for CTD review and submission.
- Data-driven Decision Making – Leverage gLIMS, SAP, Informa, gQTS, and statistical models for process analysis and reporting.
- Risk Assessment & Change Control – Identify potential risks in pharma manufacturing and implement change control strategies.
- Continuous Process Improvement – Apply Lean Six Sigma, Kaizen, and CAPA methodologies to optimize operations.
- Coordinated the preparation and review of supporting documentation from exhibit batch phase to process validation batches to ensure regulatory compliance
- Worked on post approval changes for US market
- Investigating Manufacturing deviations
- Stakeholder & Vendor Management
- SOP & Documentation Management
- TT Master Plans, Process Validation Reports, Analytical Transfer Protocols.
- Training & Upskilling – Conduct gLIMS, gQTS, SAP, Informa, and Technology Transfer training for teams at receiving sites as train the trainer.
- Lessons Learned & Best Practices – Capture insights from process deviations, CAPAs, and change control activities for continuous improvement.
- Pharma Knowledge Database Management – Organize and manage pharma-specific knowledge portals using tools like SharePoint or internal KM platforms.
- Ability to analyse complex data and share key process and business inferences/insights with the leadership team
- Ability to project manage complex change initiatives by partnering with clients
- Skilled at working independently and collaboratively in a team environment.
- Proven ability to learn quickly and adapt to new situations.
- Passionate about learning and committed to continual improvement.
- Used critical thinking to break down problems, evaluate solutions, and make decisions.
- Proved successful working within tight deadlines and a fast-paced environment.
- Demonstrated strong organizational and time management skills while managing multiple projects.
Officer | Quality Assurance
Inception Source Drugs & Pharmaceuticals
HYDERABAD
08.2014 - 07.2020
- Coordinate with cross functional teams for identifying the appropriate Corrective and Preventative Actions (CAPA's).
- Provide advice to requesting departments regarding GMP aspects.
- Responsible for periodic review of Standard Operating Procedures and Standard cleaning procedures.
- Responsible for assessing the proposed change requests for consistency, relevance, GMP compliance and Impact on safety, integrity, strength, purity and quality of the drug product.
- Identification of continuous improvement opportunities, tracking and implementation of identified actions.
- Sampling of raw materials, packed materials, in-process materials and finished products to check quality against the approved specifications.
- Ensures that all product which has been identified as potentially having a quality issue is acceptable for release, and the reports have been updated accordingly.
- Facilitated compliance with industry regulations and safety standards.
- Streamlined operational workflows to enhance productivity and reduce delays.
- Developed training materials and mentored junior staff on best practices.
- Implemented quality control measures to ensure product consistency and reliability.
- Established effective relationships with key stakeholders both internally and externally for increased collaboration opportunities.
- Coordinated cross-functional teams to address complex issues, leading to more efficient problem-solving processes.
Assistant Professor
Sri Padmavathi School of Pharmacy
TIRUPATI
01.2012 - 12.2013
- Delivered lectures on pharmaceutical formulation, regulatory guidelines, and quality control practices.
- Guided students in research projects related to drug delivery systems and process optimization.
- Published research articles in international journals and presented findings at scientific conferences.
- Mentored students in research methodologies and critical thinking skills.
- Collaborated on interdisciplinary projects enhancing educational programs.
- Evaluated student performance through comprehensive assessments, identifying areas of improvement and providing targeted feedback for growth.
- Maintained an up-to-date knowledge of subject matter by attending conferences, workshops, and webinars relevant to the field of study.
- Mentored students and communicated internship and employment opportunities.
Education
Ph.D. - PHARMACEUTICAL SCIENCES
SRI PADMAVATHI MAHILA UNIVERSITY
TIRUPATI11.2025
M.PHARMACY - DISTINCTION
SRI PADMAVATHI MAHILA UNIVERSITY
TIRUPATI12.2011
B. PHARMACY - DISTINCTION
JNTU
RAJAMPET05.2009
Skills
- Supportive interpersonal skills
- Collaborative teamwork
- Customer engagement
- Effective problem resolution
Certification
- Project Management Professional (PMP)
- Informa Statistical Tool – Trained Site Administrator & Trainer
- Trained by global SME on Quality Risk Management
- Trained on investigation tools like DMAIC
- Trained in gQTS (Global Quality Tracking System)
- Six Sigma Yellow Belt Certified
Publications
- Patent for phytosomes of p-coumaric acid with enhanced drug release activity and preparation thereof, 202341067406
- QbD Approach for the design optimization and characterization of Piperine phytosomes to enhance bioavailability, Scopus Journal - European Chemical Bulletin, 2022, 11, 11, 547-567
- Formulation and characterization of Chrysin loaded phytosomes and its hypoglycemic effect on streptozotocin induced diabetic rats, Scopus Journal - Latin American Journal of Pharmacy, 2023, 42, 3, 1726 – 1752
- Formulation and evaluation of Granisetron hydrochloride mouth dissolving tablet, International Journal of Pharmaceutical Sciences, 1, 2, 09/01/09, 336-341
- A Comprehensive Review on Phytosomal Drug Delivery Systems, International Journal of Current Research in Life Sciences, 07, 09, 2727-2729, 09/01/18
Disclaimer
I hereby declare that to the best of my knowledge and belief the information given above is true and correct.
Awards
- Best Oral Presentation Award, Sri Venkateswara Institute of Medical Sciences University, 2018
- Best Paper Award, International Conference, Sri Venkateshwara University, 2019
- Qualified in GATE (Graduate Aptitude Test in Engineering), IIT Roorkee, 2009
Timeline
Associate - MSAT
Pfizer Healthcare India Pvt Ltd
08.2020 - 12.2022
Officer | Quality Assurance
Inception Source Drugs & Pharmaceuticals
08.2014 - 07.2020
Assistant Professor
Sri Padmavathi School of Pharmacy
01.2012 - 12.2013
Ph.D. - PHARMACEUTICAL SCIENCES
SRI PADMAVATHI MAHILA UNIVERSITY
M.PHARMACY - DISTINCTION
SRI PADMAVATHI MAHILA UNIVERSITY
B. PHARMACY - DISTINCTION
JNTU