Prosenjit Das Email & Phone Number

Mumbai, Mh, In

Mumbai, Maharashtra, India

1. Review of SDLC deliverable I.e VMP, URS, Tracebility Matrix, FRS,Test strategy,2. Monitoring of QI,CAPA,DNCQA through trackwise3. Handling of JIRA/ confluence/ LMS/ELVIS

Mumbai, Maharashtra, India

Mumbai Area, India

• Participate in regular third party/LL manufacturing site audits (Participating More than 300 audit) and ensure compliance with cGMP and international regulatory requirements. Identification and Monitoring of KPI and Quality Metrics for CMO. Ensure effectiveness in the deployment of quality processes through conduct of periodic assessments of identified KPI and identify opportunities for improvements and help implement the same. Responsible for investigation & Closure of Market Complaints, ,CAPA, monitoring of Recall, Deviation, and Change Control, Risk Assessment, OOS. Developing Relationships, negotiating issues and communicating KPI with the third party manufacturer. Work closely with cross functional team such as Business Development for CMO identification & New Product development. Preparation and review of Service Level Agreement with CMO. Conduct Technology Transfers and Stability Studies Data Review. Review and update SOPs and conduct trainings on quality processes as and when required. Responsible for ensuring quality assurance and regulatory compliance while preparing label text for new products or/and artwork approval through Automated System. Responsible for preparation, review and approval of manufacturing and regulatory documentations like COAs, Dossier Compilations, New Product License documents related to Contract Manufacturing activities. Implementation of quality system Hub and monitoring through periodic audit.

Mumbai Area, India

• Handling of Product complaint management, CAPA, Cold Chain Management System, Market Return, Recall, Deviation, Change control. Oversee and monitor the compliance to GDP across domestic depot by reviewing the systems to ensure effective implementation of system at depot level and improvement in the current system by periodic review. Review of BMR, QC Document and Release of product through SAP. Coordinating with testing agencies for various product KPI and Quality Metrics to be conducted, their reports & documenting the same for future references. Monitoring of Inkjet coding/stickering activity required for DPCO & various institution purpose. To review of SOP’s to ensure that current guidelines and updates are included in relevant procedures. To ensure Schedule training programs are followed and conduct training sessions as per schedules. Compliance and response to audit observations. Providing repacking/redressing related guideline as per directive.

Kolkata Area, India

• Preparation & submission of Dossier for different Regulatory country (India, EU, UK Africa, SEA, CIS,SAARC) for the product OTC, Cosmetic Product, Herbal/Ayurveda medicine, Food Supplement. Handling of complaint received from oversees customer. Dossier preparation and query handling. Preparation and submission of drug license application to state FDA/CDSCO. Audit of different manufacturing site to meet regulatory requirement Review & approval of Claim & formulation in the label as per the regulatory guideline of various country including India Coordination of marketing, sales, R&D department regarding the development of new product. Handling different licensing activity like: SASO certification, Halal India Certification, UK Intertek product registration etc.

Kolkata Area, India

• Actively participate in the design of different quality system activity through automated system. Core team member in the software validation (Metric Stream) Handling of change control, deviation, Out of specification, Change control, DMS (Document management system) through automated software system (Metric Stream). Handling of complaint management through Ultimus. Handling of training Management Module through automated system. Handling LIMS (laboratory management system) Handling of deviation, Out of specification, Corrective and preventive action, Failure investigation, change control management Handling of regulatory queries and Regulatory review of change control. Preparation of cleaning, process validation protocol and task report Preparation of standard operating procedure Audit faced: USFDA, TGA (Australia), KFDA, Customer audit, WHO GMP Audit, GMP Audit Compilation of annual product review. Vendor qualification and audit to different vendor. Co-ordination of monthly MRM and other ISO 9001, 14001 compliance activities Member of SME groups related to Investigations & Root Cause Analysis, Risk Assessment. Review of URS, DQ, IQ, OQ protocol report.