Prashant Holkar Email & Phone Number

Mumbai, Mh, In

India

Currently working as APAC Commercial Quality Head of Sandoz (a Novartis Division) at Mumbai. Primarily leading Country Quality Organizations, QA Oversight for Pharmacovigilance and Clinical activities, CMO quality oversight, Auditing and remediation management, Site GxP compliance, Product and Supplier Qualification as per current regulatory requirements.

Mumbai, Maharashtra, India

Currently working as Head Quality Assurance in Commercial Country organization of Sandoz Pvt. Ltd(a Novartis Division) at Mumbai. Primarily responsible for Country Quality Organizations, QA Oversightfor Pharmacovigilance and Clinical activities, CMO quality oversight, Auditing and remediationmanagement, Site GxP compliance, Product and Supplier Qualification as per current regulatoryrequirements, Technology and Product Transfers and Evaluation of Contract sites for Product Risk… Show more Currently working as Head Quality Assurance in Commercial Country organization of Sandoz Pvt. Ltd(a Novartis Division) at Mumbai. Primarily responsible for Country Quality Organizations, QA Oversightfor Pharmacovigilance and Clinical activities, CMO quality oversight, Auditing and remediationmanagement, Site GxP compliance, Product and Supplier Qualification as per current regulatoryrequirements, Technology and Product Transfers and Evaluation of Contract sites for Product Risk andManufacturing Controls.Additional role as Sandoz NCQ Quality Business Partner (from April 2019 till date) for APMA regions todrive and co-ordinate Sandoz business priorities with internal stakeholder management.Key Responsibilities- Country Quality Leadership and Regional Key Project leadership- Quality Management System Implementation, Monitoring and Control- Quality System upgradation as per Regulatory Updates- Contract Manufacturing and Supplier oversight- Audit and Inspection Planning, execution and Management- Key Project Monitoring and Tracking- New Product Assessment and Launches- Quality support for new BD&L Deals or Initiatives- Escalation Management and Risk Controls- Leading Operational Excellence Show less

Navi Mumbai

Quality Leadership for Sandoz India Business and Extended ad. interim Country Quality businessPartner for Sandoz Asia 2 Cluster (till July 2018) supporting local country quality associates forEscalation Management, KPI monitoring, Quality Implementations, local Risk remediation’s, Audit actionmanagement, Quality plan executions, decision making on behalf of regional Quality and Handling ofProduct supply issues.

Mumbai, Maharashtra, India

Quality Operations for Contract Manufacturing and Country QA Operations- Supplier QA oversight- New Product Launch- Auditing and Remediation's

Mumbai Area, India

Quality Operations for Contract Manufacturing and Country QA Operations- Key Project Lead - Supplier and Product Qualification

Daman

Worked as Manager in Process development Laboratory (PDL) of Alkem Laboratories Primarily,responsible process optimization (Solid Dosage Forms like Tablets (IR, ER, CR, Bilayer), Capsules,Pellets and smooth manufacturing of exhibit batches for regulatory markets. Technology Transfer forcommercial Validation for regulated Markets like USA, Europe & ROW markets etc.Leadership qualities demonstrated with increased efficiencies for manufacturing and Submission ofANDA’s in US/ EU… Show more Worked as Manager in Process development Laboratory (PDL) of Alkem Laboratories Primarily,responsible process optimization (Solid Dosage Forms like Tablets (IR, ER, CR, Bilayer), Capsules,Pellets and smooth manufacturing of exhibit batches for regulatory markets. Technology Transfer forcommercial Validation for regulated Markets like USA, Europe & ROW markets etc.Leadership qualities demonstrated with increased efficiencies for manufacturing and Submission ofANDA’s in US/ EU Market through proactive project management and highly result oriented teambuilding.Participation in various regulatory audits like USFDA, EU and WHO (Geneva) for Process Developmentfacility GxP maintenance and Product Development. Show less

Daman

Process optimization for ANDA's, Technology Transfer, Site Transfer, Commercial Launches

Hyderabad

Worked as Assistant Manager (Technology Transfer), primarily, responsible for Product transfers (SolidDosage Forms) for regulated Markets like USA, UK / Europe markets etc. Current job responsibilitiesinclude:Project co-ordination, execution and subsequent technology transfer of product pertaining to regulatorymarkets. Planning and execution of Pre-exhibit/Scale up and exhibit Batches for regulatory market.To co-ordinate process validation activities for new/ existing… Show more Worked as Assistant Manager (Technology Transfer), primarily, responsible for Product transfers (SolidDosage Forms) for regulated Markets like USA, UK / Europe markets etc. Current job responsibilitiesinclude:Project co-ordination, execution and subsequent technology transfer of product pertaining to regulatorymarkets. Planning and execution of Pre-exhibit/Scale up and exhibit Batches for regulatory market.To co-ordinate process validation activities for new/ existing products as per agreed time lines andregulatory requirements. Reviewing Batch Manufacturing Record, Master Formula Cards, scale upreport, change control proposals, process deviations. Review of Exhibit/ commercial batch documentslike Process validation protocol, post validation reports and investigation or justification reports.Troubleshooting and Process improvement of regulatory and non regulatory products. Show less

Nashik, Maharashtra, India

- Technology Transfer- New Formulation Development- Reformulation- Trouble Shooting- Product Development Documentation- Change Control Assessments

Master Of Pharmacy, Pharmaceutics

Activities and Societies: Cricket Team

Bachelor'S Of Pharmacy

Activities and Societies: Cricket Tournaments, Lead students society