Sailendra Das Email & Phone Number

Mumbai, Maharashtra, India

Subject Matter Expert for the Pharmaceutical Lifescience software.Lead end-to-end CSV activities for SaaS/Cloud applications, ensuring 21 CFR Part 11, GAMP5,and EUGMP Part 11 compliance.Drive Agile-based software development and upgrades, coordinate with stakeholders and prepare validation deliverables.Perform GAP analysis, risk assessments, Preparation of Software Requirements Specifications (SRS) and collaborate on release plans with cross-functional teams.Oversee incident investigations and CAPA execution, improving system efficiency and audit readiness.

Bhiwadi ,Rajastan

Directed validation and compliance for Production, and software upgrades, aligning with GxP, EU Annex 11, GAMP5, and other regulatory standards.Preparation, approval, and execution of the GAP analysis, Risk Assessment, Validation Master Plan, IQ, OQ, and PQ Documents.Authored key validation documents, managed CAPA, and spearheaded system decommission processes.Successfully handled TrackWise-based change controls and deviations.I'd like for you to perform different vendor audits according to the regulatory requirements and compliance with various regulatory Audit observations and queries.

Dahej, Gujarat, India

Conducted equipment and system qualifications, ensuring adherence to global regulatory standards.Delivered robust change management processes, significantly reducing audit observations.

Goa, India

Orchestrated validation activities for advanced pharmaceutical equipment, ensuring regulatory compliance.Played a pivotal role in the successful audits from international regulatory bodies.

Goa, India

Under the supervision of Production Section Head /Production Head, coordinates and controls production activities in granulation Section which includes Regular production area activities along with Performing Calibration, Qualification, Re qualification of the Equipment, and Instruments Inventory management.

Goa, India

 Manage a team of 30 Peoples engaged in coating and inspection process, while also working to advance coating capabilities.  Providing department leadership, work direction and training to employees  Preparing cost and material requirement estimates for quotes  Working with R&D to resolve complex designs and technical problems Determining coating equipment capability/test accuracy and recommending equipment upgrades, modifications and/or improvements  Performing QRM , Determining CAPA for failed coating runs and initiation of QMS activity Overseeing department preventative maintenance program, Qualification of area and equipment. Implements production Long term plan/targets and Unit dispatch commitment.  Helps Team to achieve company goals by communicating expectations, planning, monitoring, and evaluating job results. Keep team readiness for inspection and prepare compliance report related to coating section. Performing FAT , Preparing related URS, QRM, Qualification Protocol and Standard Operating Operation

Goa, India

Under the supervision of the Production Section Head/ Production Head, coordinates and controls production activities in Compression & Coating Section which includes Regular production area activities along with Performing Calibration, Qualification, Requalification of the Equipment and Instruments Inventory management.

Master Of Business Administration - Mba, Operation

Bachelor'S In Pharmacy, Bpharm

Education record

Ipt,Salipur ,Cuttack, Odisa, Pharmacy