Rahul Bedre

Experience

• 

  Lupin

  Nov 2016 - Feb 2017

  Marketing Executive

  • Identify and map key stakeholders in the assigned geography to implement company marketing campaigns and projects.• Engage with healthcare professionals regularly to detail and promote company products, handle queries and objections, and secure prescriptions.• Adhere to sales effectiveness KPIs, including call average, frequency, coverage, and personal order booking.• Meet with stockists to ensure timely product supply and maintain adequate stock levels for pharmacies.• Conduct prescription audits with pharmacies to screen doctor lists, evaluate previous visit outcomes, understand competitor strategies, identify competitor prescribers, book orders, and ensure product availability.• Assist the Area Sales Manager in strategically segmenting healthcare professionals for high-value inputs.• Provide feedback on competitor activities and other relevant developments to sales leadership.• Conduct promotional events and other activities as needed, with appropriate approvals.• Maintain discipline in completing processes such as daily call reporting, monthly reporting, and updating healthcare professional contact cards. Show less

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  Zydus Group

  Feb 2017 - Apr 2020

  Manufacturing Operations Specialist

  Supervision for batch manufacturing of sterile injectables.Purchase Order creation and amendment through SAP.Consumable and other raw Material Issuance and Dispensing.Perform CIP, SIP, PHT of Compounding and Holding vessels.Complete GMP documents, such as Batch Record, cleaning & sanitizing logs and otherdocuments pertaining to manufacturing.Follow safety rules/regulations and report any workplace injuries or accidents.Compounding batches as per SOP’s and Master Formulas.Participate and assist with continuous improvement projects and processes.Complete all GMP Documentation aligned with RFT & ALCOA principal.Complete all training assignments and maintain personal training records.Participate in and lead Investigations.Implement Corrective and Preventive Actions (CAPA’s).Initiate, and follow through with actions required to close Change Controls.Participate in Internal, Customer and Regulatory Audits.Assist Validation staff with new formulations and scale ups. Show less

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  Lupin

  Jun 2020 - Nov 2021

  Quality Assurance Specialist

  In-process Quality Checks and Compliance. Ensure Line clearance at each stage of Batch Manufacturing. Document life cycle Management. Review of BMR, BPR, and other batch related documents.Review and approval of records like calibration, sanitation, and training records.Review and approval of breakdown reports.In process sampling and quality checks. Perform Acceptance Quality Level Checks throughout the process.Perform Sampling at various stages. Perform Visual inspection of media filled vials.Visual inspection kit preparation and it's qualification. Training and qualification of visual inspectors.Audit compliance and readiness for regulatory audits.Adhere to all Company policies and procedures for GMP/GDP and health-safety.Support in qualification of new equipment. Show less

• 

  Pfizer

  Nov 2021 - now

  • Perform Due Diligence Quality (DDQ) assessments for suppliers.• Review documents and perform batch dispositions for the EU market.• Review and approve documents related to product development, analytical data (both electronic and chromatographic), and instrument and equipment qualification.• Ensure data integrity and SOP compliance for both hard copy and electronic records.• Perform audit trail reviews in accordance with 21 CFR Part 11 requirements.• Ensure compliance in microbiology and chemistry labs during daily activities.• Connect and communicate with local and global business lines (BL) and Operations Quality (OQ) colleagues to meet objectives.• Drive effective management of quality issues and investigations, including handling moderately complex quality and technical issues.• Escalate issues by notifying the manager as needed.• Recommend and proficiently apply quality/risk management tools for problem-solving and issue resolution.• Participate in implementing new initiatives and goals within the QA function and with business line partners to drive consistency, efficiency, and compliance.• Ensure audit and compliance.• Provide responses to internal and external audit observations. Show less • Conduct internal audits and ensure compliance with regulatory standards.• Address internal and external audit observations promptly.• Drive continuous improvement and process simplification initiatives.• Supervise manufacturing activities to ensure adherence to quality standards.• Initiate and implement change controls effectively.• Perform procedure vs. gap assessments and ensure compliance.• Initiate emergency and planned temporary change requests.• Conduct manufacturing investigations to identify root causes and implement corrective actions.• Initiate, review, and implement CAPA (Corrective and Preventive Actions) and EC (Engineering Change) processes.• Ensure shopfloor compliance to achieve batch targets.• Review and approve manufacturing records.• Prepare and revise GMP (Good Manufacturing Practice) documents.• Perform scheduled and ad-hoc walkthroughs to ensure compliance and identify improvement opportunities.• Identify and implement process simplification projects.• Ensure continuous improvement in manufacturing processes.• Plan and schedule manufacturing activities efficiently.• Provide GMP training to colleagues to maintain high standards.• Support the closure of batch records to ensure timely product release. Show less

  • Quality Assurance Compliance Specialist

    Apr 2024 - now

  • Manufacturing Compliance Specialist

    Nov 2021 - Apr 2024