Shrinivas Nayak

I am a Quality Assurance Professional with 16 years' experience. I hold a Master's In Pharmacy in Quality Assurance. I am looking for the opportunity to advance to a Management position where I can use my skills in developing strategies and leading a team.

• My current work profile in Vendor Management is to Manage the Vendor Change notifications,Rejections, investigation, Conduct Audits, performance evaluations.The company is working on a SAP hana upgradation and automation projects in Vendor Management system transforming from manual system.
• Achieved for the previous company certification ISO13485:2016 Quality Management System Regulatory Requirements for medical device from the Notifying Body-DNVGL Presafe CE accreditation for a sterile tissue adhesive medical device.

Implement,Operate,MonitorandMantainQualityManagementsystemenablingoperationsat sitetooccurinanefficientmannerandcompliancewithglobalqualitystandards.  SubjectMatter Expert for theVendorManagement Systemacross themanufacturingunit includingAudits/RiskAnalysisw.r.tQualityandBuisnessneeds

 To coordinatewith LupinQP for vendor audit &compliance report andQuery response, continuousimprovementsrelatedtoallvendorqualification.

IndependentlyperformRM/PM/CMOAudits.LeadAuditorforVendorManagementSystemsand compliance.Performed 300+RM/PMauditsDomestic/Overseas.

Evaluate/investigateChangeControls /Deviations/Market Complaints/OOS /CAPAs, internal Auditfindings,ExternalAuditfindingsandproposeCAPAsforCorporateQualityandsite.

 ProvidingGuidance to the teamonquality/compliance riskand timelyclosureof theQMS Documents. HandlingProjectandtechnicaldocumentationforISO13485:2016QMS-Medicaldevicefortwo sites&CEcertificationforsterileTissueadhesiveMedicalDevice.Achievedthecertificationin January2022.

 Responsible for Review and Approval of all departmental SOP's, Packaging material specification,Billofmaterial,Artworks.ResponsibleforGMPCorporateQAatR&DFacility.

ConductingQualityManagementreviewmeetingswithSiteQA.

 Act as a key teammember for Operations, R&D, Purchase, PPIC, Site-Quality, Packaging development,RegulatoryandothersupportinggroupstofacilitateinvestigationsforContinuous QualityImprovement. ActasakeyteammemberforAuditCompliancewrite-upforSitecGMPRegulatoryinspections Designing of Protocol/Execution of Process Validation for Transdermal Patch Brazilian Market.

 Evaluation of quality systems and practices, to identify potential problems /gaps such as NonConformance to cGMP /SOP/Quality Standards.

 TopreparetheAudit reports and communicate to the external /internal stakeholders.

 To track audit the responses and auditee CAPA until satisfactory completion and closure. Periodic Evaluation of Vendors.

 Responsible for Risk Analysis of Vendor as per European Directives.

 Handling Vendor Complaints, Qualification of Auditors, Audit Management through SoftwareCaliber.

 Responsible for Training at all levels for department on basic and Advanced GMP/Quality System. Assist in developing process including development and implementation of Continuous Quality improvement.

 Monitor and co- ordinate with site for its readiness to cGMP Regulatory inspections /Customer Audit.

 Review the Master Manufacturing Formula card for technical aps/ impact/corrections. Review Site Product Quality Review as and when required.

 Responsible and accountable for SAP Projects related to Automation of Supplier Qualification.

 Responsible for making a healthy environment of the CQA team to work effectively,ensure team work and utilize skill set for benefit of company while working with 7 members.

 ReviewofMasterBatchmanufacturing records

 ReviewofCalibration Certificate status of equipment's

 Review of Stability reports (Client, R & D Projects) and Technical data package (Raw/Packaging/in-Process/Finished Product material

 Verification of Validated spreadsheet

 Preparation of SOP's,Stability Protocol

 Responsible for Market search of Stability & Loan license clients for the product launch\Technology Transfer, Conducting interview for expansion of department

 HandlingClient related Quality Questionnaires

 HandledSOPGapassessmentcompliance audit of the facility

 Optimization and Process Validation of Dry Powder Direct compression for tablets,Technology Transfer Execution & its related

 Documentation(Pre-formulation) at Loan License sites

 Checkingandapproving the Batch Process Records before execution

 Preparing / Reviewing the Annual ProMaking sure that all deviations are investigated and resolved before the release of the batch, Document control and maintenance of Loan License/Third Party

 Development & Documentation) /Technology Transfer Documentation (formulation aspect) as and whenrequired

 Readinessfor Self-Inspection/Pre-regulatory Audit (MHRA,USFDA,EDQM)

 Monitoring, Handling Vendor Complaints (RM/PM) & CAPA for the complaints.

 Conducting Vendor audit and getting Compliance(LL/Third Party/RM-PM Vendor Development & Documentation)

 Execution of Technology Transfer & related Documentationformulation aspect)

 Datacompilation for Annual Product Review.

• Health Canada 2019, Dr.AJ.Van Zyl International GMP inspection2019 ,SAHPRA(MCC) 2018 (OSD & Injections), Ukraine(PIC/S) 2017 (OSD, injections),Transdermal Patch, Liquid Orals),Russian Ministry Health Inspection 2018(Injections, OSD),DNVGL Presafe for ISO 13485:2016 & CE (sterile tissue adhesive),Ethiopian FDA ,Tanzania FDA & CustomerHandled Audit & Achieved the company with NSF cGMP certification (USFDA CFR Part 211 for dietary supplements)Handling Customer &Regulatory Audits for Loan License/Third Party/ Vendor Development & Documentation.

NSF certified Lead Auditor PQS 2025.

Pharmaceutical Quality System by Dr.Van Zyl 2019,21CFR Part 11 Data integrity with Computer System Validation 2019, Lean Six Sigma White belt certified April, 2020.,Lean Six Sigma green belt certified,Seminar for Frequent US FDA Observations 2019 & How to Respond to FDA by International Society for Pharmaceutical Engineering( ISPE) APRIL,2020 , USP Certification course for fundamentals of GMP:Auditing,Data integrity and CSV,HVAC Qualification April 2020.,Issue management anddeviation by Qualistery

• Singen Valid until 2027 November.
• USB1B2 - Expired
• Japan- Expired
• Taiwan -Expired