Kapilkumar Shinde Email & Phone Number

Bengaluru, Ka, In

Bengaluru, Karnataka, India

1. Working within the Quality team responsible for overall management of Learning operations within Tenshi Kaizen.2. Responsible to drive Regulatory Intelligence within the organisation.

Bangalore

Training Operations:Development and Implementation of OrganizationalImplementation of Digitized solution across Biocon for Training management and support as a Training service.Identification of Key Learning Needs for the Organization through Department Scorecards and Learning Surveys.Design , Development, and Implementation of Key Learning programs using instruction design for every financial year and its Facilitation.Development of the Training Effectiveness methodologies for various trainings carried across Biocon.Reporting and Tracking of Business Training performance through agreed KPIs and KQIs.Collaboration with different stakeholders for Skill development and understanding the Site Training Scenario.Delivering different Operational Excellence initiatives through Training Learning Strategy through Business Suitable Process.Project Management:Project Managed implementation of enterprise Learning software- SAP SuccessfactorsProject Managed Implementation of APQR software within Biocon Limited

Bengaluru, Karnataka, India

GXP Training Management across Biocon Limited.

Bengaluru, Karnataka, India

Central Learning Operations at Biocon

Navi Mumbai

Preparation of the training calendar yearly for annual refresher trainings.• Training Need Identification of all employees after discussion with all HODs & approval• Interact with Corporate & Global QA / Training for QMS training• Organize External Training & Webinars for employees.Preparation review and execution of Training effectiveness check at Site.• Support implementation & Resolve issues w.r.t. LMS.• Preparation of Questionnaire for the Technical Training Module.• Provide the Training to the BOAT.• Monthly report compilations and submission on time.• Prepare and update Quality review meeting report and present site meeting.• Line Clearance Effectiveness Check certification.• External Training Updation in LMS.• Review Training Files and Other System Documents and provide support during the audits for all FDF locations

Indore Area, India

• Function as In Charge of Tech Training for Indore site.• Preparation of the training calendar yearly for annual refresher trainings.• Training Need Identification of all employees after discussion with all HODs & approval• Interact with Corporate & Global QA / Training for QMS training• Organize External Training & Webinars for employees.• Prepare, Review & Approve all Training Materials, Modules, Tech training SOPs, and miscellaneous protocols.• Review & Develop New Training Modules & Implement • Trouble Shooting in Learning Management System.• Conducting Classroom Training  cGMP: MHRA, WHO and CFR Guidelines Quality Management System Root Cause Analysis Quality Risk Management Validations & Qualifications GDP and Data Integrity  Internal Audit and Auditors Qualification MyUniversity Orientation to novice  F and DC act 1940 FDA India (Schedule M) – Require mandate for Certification on employee by Government of India.• Keep the site all time ready with respect to Training.• Content Management in LMS related to Global/ Regional Sops, different policies, Refresher Trainings and Modules.• Tracking and Monitoring of all Employees Training• Preparation of the Training questionnaires and training material for LSSDC Manufacturing operators and supervisor certification program.• Preparation review and execution of Training effectiveness check at Indore Site.• Support implementation & Resolve issues w.r.t. LMS for other sites of Mylan.• Preparation of Questionnaire for the Technical Training Module.• Provide the Training to the Bench Strength Employees.• Monthly report compilations and submission on time.• Prepare and update Quality review meeting report and present site meeting.• Line Clearance Effectiveness Check certification.• External Training Updation in MyUniversity.• Review Training Files and Other System Documents and provide support during the audits for all FDF locations.•

Aurangabad Area, India

• Responsible for overviewing of sterile operations line cleaning and sanitizations and it validations and maintenance.• Responsible for validation of processes in yearly manner, preparation, analysis, review of validation activities to closing of report.• Responsible for Review and approval process of the various SOP, BMR and MFMs.• Responsible for Manufacturing to quality coordination in view of NCR and Change control management in track wise 8. • Responsible of carrying validation of computer systems like instruments, PLC, recorders along with software as per 21 CFR and GAMP5 as per current cGMP regulations for computer systems.• Maintaining and operating in budgeted head counts in year. Handling of team of 13 persons.• Maintaining of Training cycle for calendar year.• Maintaining the CPM of the customer complaint matrix in FFS.• Regulate, received and raised ICAR or SCAR tracking and its investigation.• SPOC from manufacturing to quality for coordination and front lead in Regulatory, Local and internal audits.• Responsible for training and skill development of personnel as per requirement.• Responsible for handling of NCR, CAPA, Audit compliances and various quality systems attributes.• Certified Level 2 GMP trainer for Waluj Site.• Certified NCR investigator for Waluj site.New product and experiences in medical device manufacturing of peritoneal dialysis solution with CAPD kit.

Mahad

• Preparation review and implementation various validation protocols.• Conducting validation activities with department and its periodic review.• Preparation of validation report.• Responsible for Manufacturing to quality coordination in view of NCR and Change control management in track wise 8. • Responsible of carrying validation of computer systems like instruments, PLC, recorders along with software as per 21 CFR and GAMP5 as per current cGMP regulations for computer systems.• Responsible for preparation of BMR, SOP and MFR for desired products.• Association with manufacturing science and technology team to aware about validation processes inside company and second Eye to QA.• Leading in front in any regulatory, internal as well as local audits. Observations noting and its compliance tracking.• Leading for the information security site coordinator.• Completed M zero level Fundamental Leadership Training at Mumbai for basic leadership skills.• Responsible for Quality to production coordination in view of NCR and Change Control management in Track wise 8.• Responsible for Training and Skill development of personnel as per requirement. Maintaining of the same in STLS module (Training assignment and completion).• Responsible for maintaining various matrixes related to quality, manufacturing and safety.• Responsible for handling of CAPA, deviation and Change control.• Certified deviation investigator for Sandoz Mahad site.

Ankleshwar

• Responsible for batch planning and laboratory activities.• Responsible for Sterile operation handling, Validation maintenance of sterile operations like CIP/SIP.• Responsible for Validation of process. Preparation, Analysis, Review, Execution and closing of validation protocol to report.• Responsible for quality related documentation.• Responsible for testing of product level in fermentation sample.• Responsible for purity testing and contamination review.• Responsible for shake flask experiment carrying as per approach.• Responsible for seed media transfer to manufacturing and inoculation to fermenter.• Responsible for aseptic handling and maintaining clean room practices in laboratory.

Tarapur

• Responsible for batch manufacturing activities.• Responsible for Sterile operation handling, Validation maintenance of sterile lines, sterile operations handling like Media sterilization, Empty Sterilization of fermenters, water sterilization in small fermenters, pre seed maintenance and inoculation.• Responsible for downstream processing of fermented broth.• Responsible for processing of reactions like precipitation, decantation and Neutralization of Rifamycin B.• Responsible for BMR, Log Books and other record maintaining.• Responsible for in-process analysis of fermented broth for pH, PMV (Packed Mycelia volume), Dextrose content and viscosity.• Responsible for contamination prevention in fermentation batches.

Master Of Science (M.Sc.), Microbiology, General, First Class

Bachelor Of Science (B.Sc.), Microbiology, General, First Class