Suraj Jagtap Email & Phone Number

India

- Guide and provide inputs in development of new features and enhancement of product by understanding customer needs and requirements.- Evaluate and approve changes in product in compliance with 21 CFR and EU Annex 11.- Maintain effective quality control processes with SDLC principles to produce fruitful deliverables.- Guiding team to validate the products according to GAMP5. - Responsible for reviewing and approving various validation deliverables such as Validation Master Plan, Requirements Specification, Test and/or Qualification Plan, IQ, OQ, PQ, Traceability Matrix, VSR etc.- SLA and TAT compliance. - Responding customer complaints and eventually reducing complaints and nonconformities by investigation implementing appropriate CAPAs.- Ensure implementation of IT Policies, SOPs, and Guidelines at organization level.- Responsible for conducting Internal audits and hosting External Audits.

Ahmedabad, Gujarat, India

Working with a dedicated team of Software Developers for the enhancement, upgradation, scale up, branding & pre-sales of regulatory solutions for Quality management systems, Training Management, MES, electronic logbooks. Explore new used cases and carve solutions to reach client anticipations.1. In depth understanding of EU Annex 11, 21 CFR Part 11, ALCOA++ and QMS. 2. Maintain QMS expertise and understanding of Regulatory guidelines and response to Client.3. Requirement Gathering from clients for Regulatory Products.4. Responsible for understanding and analyzing requirements from client and stake holders.5. Support clients to update URS as per the regulatory requirements for computerized system.6. Process user requirement specification understanding and Analysis in the conjunction with software developer team. 7. Project management planning for implementation.8. UAT, User Training and subsequent issues management if users come across.9. Project documentation review (i.e., RA, DS, FS, UAT, IQ, OQ, PQ, TM, VSR and other relevant validation documents).10. Along with solution deployment, provided functional support to multiple clients for establishing their end to end eQMS, TMS, eBMR operations etc.11. SOP Management, CR Reviews and Quality Management of Products.12. Participate in Audits and QMS Management and monitor testing of solutions before releasing in Live environment.13. _Provide presentation & solution demonstration of pharmaceutical operation, QMS and Training management to both domestic and overseas prospect and actively involved in product branding and marketing on digital platforms like LinkedIn_14. Content management on product website and social media.15. Increase product awareness using social media, newsletter, whitepaper, webinar etc. 16. Controlling and maintaining company’s official page (QEdge and ProcessXE) by routine posting of latest regulatory updates.

Ahmedabad Area, India

Handling Overall Compliance activities through electronic QMS system "Trackwise". Tracking QMS activities and prepare Quality metrics for Management review as MIS.Support in Computerized System Validation. Review of Global audit 483 observations, internal and external audit observations to evaluate compliance of existing system in facility.Prepare response to audit observations and implement CAPA drawn through the various study protocols and RCA for observed non compliance.Preparation of Risk assessment, Process Validation protocols, cleaning validation protocol, Smoke study and their reports compilations.

Indore Area, India

Risk assessment for various activities like Area qualification and equipment qualification in brownfield project of PFS.Handling QMS activities in online EQMS software "Trackwise" for facility of Nasal Spray, DPI (Dry Powder Inhaler) and UDNS (Unit dose Nasal Spray).SOP preparation in online software "Documentum"

Ahmedabad, Gujarat, India

Overall QMS activities and Computerized system validationHandling of Market complaints, Investigation, Root cause analysis and CAPA in electronic QMS system.Key team member in digitalization (Paper on Glass) of batch manufacturing process.Vital role in computerized system validation and implementation of electronic batch manufacturing record (eBMR).

Ahmedabad, Gujarat, India

Handling Quality management systems for Injectable facility in greenfield project.Change management, Deviations, RCA and CAPA.New SOP Preparation and SOP revision.Support in equipment Qualification activities.BMR Preparation.Internal and External Audit response submissions.

Bhopal, Madhya Pradesh, India

Look after shop floor activities for manufacturing of Tablets, Capsules, Dry Syrups, Liquid preparations, Creams and Lotions.Taking line clearance, Carryout in-process activities, Supervision of dispensing activities, Potency calculations for API.Designing BMR, BPR and preparing SOPsReview of GMP documentsSupport in process validation activities.

Dewas Area, India

Preparing protocol for Equipment Qualification, Requalification and ExecutionHVAC Systems ValidationMaintaining RQ Calendar SOP Preparation

Master Of Pharmacy, Pharmaceutics

Bachelors Of Pharmacy