Dhananjay Devkar Email & Phone Number

Indore, Madhya Pradesh, India

IT Quality & Computerized System Validation Periodic ReviewQuality Management System End to End Validation of Quality Control & Manufacturing Computerized System User Access Management Data Backup Restoration Self Inspection Training on CSVVendor Qualification

Mumbai Area, India

• Lead ITQA Compliance function including the leadership, management and mentoring of staff resource.• Responsible for end to end validation of computerized system validation by preparing various validation deliverables as per GAMP 5 guideline.• Develop and maintain the IT Quality system to ensure compliance with internal/external regulatory requirements like EU Annex 11, 21 CFR Part 11 etc.• Qualification of computerized system vendors/suppliers & service providers.• Approval of relevant IT Quality procedures (SOPs).• Act as the IT focal point for internal/external audits.• Execute computerized system periodic reviews as per schedule.• Execute IT Validation projects including plans, protocols and reports.• Manage IT QA projects (including new system implementation).• Provide input into business decisions in the assessment and specification of IT requirements.• Provide support in the education of personnel in relevant areas of IT quality.• Ensure key system documentation consistently meets the required quality standards throughout its lifecycle.• Coordinate operational change management / test activities to ensure ongoing compliance with business and regulatory requirements.• Ensure IT quality processes and standards are aligned through collaboration with the Quality Assurance functions.• Approve quality related lifecycle documentation.• Develop an inventory of IT systems and infrastructure, for each assess the requirement for compliance and the current compliance status. Manage remediation programs prioritized on risk.• To lead and manage other compliance initiatives including information security, data protection and software licensing.• Implement & to ensure the user access management activity should be performed as per procedures & regulatory requirements.• Conduct training to system owner, process owner, Subject Matter Expert & user on computerized system validation & IT Compliance policies & procedures.• Report IT Quality metrics.

Bengaluru Area, India

- Computerized System Validation of Laboratory & Manufacturing Systems.- Sound knowledge of GAMP 5 guidance and requirement.- Lead cross functional team to perform the gap assessment of Computerized Systems to comply the systems as per current regulatory requirement. - Remediation of gaps.- User management of Laboratory & Manufacturing Systems as per FDA and 21 CFR part 11.- Preparation & implementation of Computerized Systems Standard Operating Procedures.- Preparation & implementation on Computerized System Validation Master Plan.- Spreadsheet Validation.- Implementation of Chromatography Networking Systems i.e. Chromeleon & Empower 3.- Validation of Standalone Computerized Systems.- Conduct the self-inspection of Laboratory & Manufacturing Computerized Systems. - Perform Supplier Assessment.- Data Backup & Restore.- Compliance to audit observation.- Periodic Review of Computerized Systems.- Preparation of periodic review of user management & audit trail schedule & monitor the activity as per schedule.- Review & Approval of Various Quality documents related to Computerized System Validation.- Retirement of Computerized Systems. - Training to team members on Computerized System Validation, Data Integrity, 21 CFR Part 11 Requirements etc.

Mumbai

- Planning & execution of calibration of laboratory instrument as per calibration schedule.- Ensuring implementation of change control, corrective action / preventive action proposed in deviation/failure investigations.- Investigation of OOS & instrument calibration failure.- Handling of analytical incidence observed during calibration.- Review of Calibration, qualification & other documents in Laboratory.- Review of calibration schedule & overview. - Instrument validation QP/R, IQ, OQ, PQ of all pharmaceutical laboratory equipment.- Sound knowledge of GAMP 5 guidance and requirement.- Carry out vendor assessment.- Complete validation activity of networking & standalone software’s. i.e. Chromeleon networking software, UV probe software, tiamo software etc.- Preparation & validation of Chromeleon report format as per requirement.- Preparation of yearly calibration schedule, preventive maintenance schedule of all laboratory instrument/system.- Preparation of data back/restore schedule of all standalone computerized system as per assigned frequency.- Periodic review of all laboratory instrument/system for re-qualification.- Preparation of periodic review of user management & audit trail schedule & monitor the activity as per schedule.- Retirement of laboratory instrument/system.- Preparation and readiness of lab, to regulatory agency & global audits.- Review of Various Quality documents related to Computer System Validation.- Computer System Validation to comply 21 CFR 11, Annex 11.- Laboratory compliance & Auditing.- Preparation and review of all Laboratory & system SOPs.- Identifying & complying gaps w.r.t GMP, Novartis guidelines, policies, SOPs current pharmacopeia changes.- Training of associates.- Implementation of lab in-control activity as per Novartis policy.- Maintaining GLP in Laboratory.

Daman

Analysis of Finished goods and semi finished product like tablet, capsules, stability samples raw materials and Calibration of QC instruments.• Sampling of raw materials, finished products and packaging material.• Analysis of finished product as per standard test procedure (STP).• Analysis of in process samples during process validation.• Reviewing of Reports of finished Product.• Preparation of Certificate of Analysis. • Preparation of Stability Protocol as per ICH guidelines • Charging of samples & chamber updation.• Analysis of stability samples.• Preparation of Stability Trend.• Compilation of stability data.• Calibration of Instruments like HPLC, UV and Dissolution Apparatus.• HPLC Column Performance.• Preventive maintenance of HPLC Systems.• Reviewing of Reports of Calibration.• Preparation of SOP for New Instruments and Equipment. • Giving Training & personnel validation of analyst.

Daman