Shaleena

I am a proactive and results-oriented Quality Assurance and Pharmacovigilance professional with postgraduate degrees in Biopharmaceuticals and Microbiology, complemented by an outstanding academic record and published research. My background includes hands-on industrial experience in Pharmacovigilance (GVP) and Quality Control within a GMP-regulated environment at one of the world's leading pharmaceutical companies, as well as research experience with a United Nations–funded organization. I am a fast learner with a meticulous, detail-focused approach to work.

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.

MSc - Biopharmaceuticals - King's College London (2016 - 2018)

MSc - Microbiology - Jawaharlal Nehru Technological University (2009 - 2011)

BSc - Chemistry, Genetics, Microbiology - Osmania University (2006 - 2009)