Akanksha Sharma Email & Phone Number

Ireland

Ireland

India

•Collaborated with BD, Client Operations, and Project Management to prepare and negotiate budgets for new opportunities and change orders, ensuring compliance with sponsor requirements and mapping to client grids within required timeframes. Accurately prepared complex client budgets using the pricing tool•Prepared high-quality, customer-focused proposal materials, researching and presenting statistics, experience tables, and company information for RFP and RFIs. Responsible for substantive editing, drafting, and formatting to ensure proposals accurately reflected customers’ requirements and were consistent with branding guidelines•Facilitated the development, negotiation, and execution of pre- and post-award sponsor contracts, liaising closely with global teams and legal department.•Led the implementation of the Ironclad contract management system, streamlining contract workflows and integration of proposal in system to improve compliance across the organization.•Participated in the trainee program initiative, sharing expertise and knowledge through live training sessions in Malaysia and Online trainings facilitating successful integration of new hires into the company culture•Played a key role in developing a pricing tool, leveraging technical skills and industry knowledge to design and implement an effective solution. •Identified and contributed to improving process efficiency and quality, performed user acceptance testing on new systems and processes.•Collaborated with global teams, BD, and Client Operations to develop materials for Bid Defense meetings. Contributed to Bid Defense preparation meetings, coordinated and participated in negotiations and discussions with clients.•Liaised with third-party vendors/alliance partners to provide quotations and/or information where required. •Mentored junior staff, providing guidance on project work, resulting in improved team performance and increased productivity. Performed quality control on final deliverables.

India

Bengaluru, Karnataka, India

Bengaluru Area, India

1. Analyze and review Request for proposal documents to identify missing information for budget and proposal preparation. Follow up with appropriate contacts such as BD, Logistics, SP team for additional information as required.2. Prepare standard documents (Texts, Budgets and Proposal) in accordance with agreed strategy with IQVIA and Q2 solution and as per Sponsor requirements and expectations under stringent timelines.3. Build Budgets (RFP, Re-bid, Reprice and Ballpark) for studies based on client information to scheduled time-frame.4. Maintain and update opportunity and Bid history status within Salesforce.5. Update and maintain Contract and Proposal related database and documents in SalesForce, Elvis and Box.6. Administrative activities such as Formatting the budget into client friendly format, pasting budget into Contracts, signed contract announcements, Award upload.7. Contribute to process improvement initiative and support implementation.

Bengaluru, Karnataka, India

1. Analyzing Out of Specification, Out of Trend, Deviation, and Laboratory Incidents.2. Implementing Corrective and Preventive Actions (CAPA) to Address Quality Issues.3. Investigating Laboratory Incidents, Out of Specification, Out of Trend, and Deviation.4. Implementing Corrective and Preventive Actions (CAPA) to Ensure Product Quality.5. Managing and Monitoring Changes to Specifications, Testing Procedures, Software, Equipment, and Facility.6. Updating Standard Operating Procedures to Incorporate Guidelines and Regulatory Changes.7. Creating and Reviewing User Requirement Specifications and Observation Data Sheets for Product Analysis.10. Conducting Training for Quality Control Personnel and Other Departments.11. Reviewing Audit Trails for In-Process and Finished Products.12. Creating and Reviewing Master Data in SAP for Specifications.Audit faced: USFDA, EUGMP, MHRA, PMDA, EMMA, ISO audit, Health CANADA, WHO GMP, Cofepris (Mexican Regulation) Iran MoH, USV, Russian audit, Abbott Malaysia, Merck & Customer Audits.

Hyderabad Area, India

DBT funded BCIL training at R&D, involved in analytical methods for pneumococcal vaccine.Project title: Compositional analysis and quality control methods for capsular polysaccharides of Streptococcus pneumoniae serotype 19A and 19F.

Indore, Madhya Pradesh, India

Master Of Science (M.Sc.), Biotechnology

University Topper

Bachelor'S Degree (B.Sc), Biotechnology, Chemistry, Zoology