Small Business Owner - ETSY SHOP - London, UK
(2024-03)
- Manage online sales, customer service, and order fulfillment
- Create product listings and promote products through social media
- Handle inventory, shipping, and business operations
Quality Assurance Specialist - Merck Sharp & Dohme (UK) Limited - London, UK
(2020-04 - 2022-06)
- Responsible for review and release of finished products (IMP, nIMP and Comparator) in compliance with GMP, Manufacturing authorization, Clinical Trial Applications and Regulatory requirements.
- Reviewing the batch manufacturing, testing, and packaging documents against the Investigational medicinal product dossier, Investigational New Drug (IND), Drug Master File, Cross reference letters and other Country specific documents (RTQ -Response to Question, EudraCT) to ascertain compliance before QP certification.
- Experienced in GMP and regulatory review of the batch manufactured for release to joint ventures, collaborators, and Investigational Initiated Studies.
- The role also involves review of, deviations, out of specifications and change records.
- Collaborating and liaising with multiple global CMC project managers, regulatory managers, and external third-party quality managers to help resolve issues.
Pharmacovigilance – Scientific Officer - Diamond Pharma Services - Harlow, UK
(2019-01 - 2020-04)
- Recording and processing ICSRs according to reconciliation with third parties based on SDEA agreement and data entry guidelines.
- Triaged various serious and non-serious case reports (ICSRs) of different medicinal products belonging to different clients in compliance with global regulations and compliance timelines.
- Working knowledge of ARIS-g database.
- Supported signal detection and PSUR preparation activities.
- Acquiring and maintaining an up-to-date knowledge of global safety regulations, safety database and documentation systems.
Master's Project - King's College London - London, UK
(2018-05 - 2018-09)
- Developed Research and analytical skills in FTIR, HPLC, MS, GC and NMR
- Acquired knowledge and experience in Scanning Electron Microscopy (SEM) and Electrospinning
- Conducted independent research and was successful in producing a novel electrospun nanofibrous scaffold which mimics the intestinal basement membrane.
- Acquired knowledge of scaffold technology, CaCO2 cell culture and cell viability techniques.
- Gained in depth knowledge on Electrospinning technique and its use in tissue engineering.
Quality Control - Technical Trainee - Dr Reddy's Laboratories Ltd - Hyderabad, India
(2012-04 - 2013-01)
- Responsible for performing biochemical analytical techniques to determine the purity of drug substances and the final drug product, adhering to GMP, GLP and GDP standards.
- Worked on Therapeutic Monoclonal Antibody Rituximab (Reditux), B-mAb (Bevacizumab) Darbepoetin- alpha (Cresp), G-CSF (V1.1) and G-CSF (V1.2) - Filgrastim and PEG-filgrastim (PEG-GCSF).
- Proficient in analytical techniques like spectroscopy, SDS PAGE, western blot analysis, osmolality analysis and isoelectric focusing.
- Wrote detailed documents like SOPs, STPs and trend preparation for stability and lot release batches.
- Closure of discrepancies (OOS).
Project Intern - International Crops Research Institute for the Semi-Arid Tropics (A United Nations organization) - Hyderabad, India
(2011-04 - 2011-10)
- Production of Helicoverpa armigera resistant transgenic pigeonpea plants of ICPL88039 variety through Agrobacterium-mediated transformation.
- Plant tissue culture experience.
- Interacted with researchers world-wide.
