ITQA CSV lead (Corporate Quality Assurance department) at Syngene International Limited)1) Project Management: Implementation of various IT project from US and Syngene pan India site for end-to-end progress with strict time deliverables. 2) Responsible for implementation of appropriate quality systems and maintain consistent compliance of GxP IT Systems to ensure Computer Systems, projects meet their business and regulatory requirements.3) Handling quality operations-Lab investigation, Deviation, Internal audit, CSV, DI, QMS, Equipment lifecycle, and documentation activities with strong interpersonal skills. 4) Perform GxP computerized systems assessment referring requirement of 21 CFR part 11, EU Annex 11, applicable regulatory standards, adequate security and controls.5) Gap Identification, Mitigation and IT SOP Compliance. Support sites for audit readiness with respect to CS validation, operational management and to comply an internal/ external audit observation. 6) Perform proactive assessment of regulatory and internal audit observations of one site/department to others. Perform periodic validation status review of computerized systems. 7) Preparation and implementation of relevant quality procedures for computerized systems (SOPs). Ensure alignment/gap assessment of sites SOPs related to Computerized System’s against global SOPs and effectiveness check. 8) Provide support/guidance to remediate legacy/non-compliant computerized systems, to ensure compliance with applicable regulatory standards.9) Evaluation of application software and hardware as per business requirement. 10) Conduct scheduled internal audit/Data Integrity audit and ensure quality and compliance at site. 11) Ensure availability of inventory of IT systems and Software license agreement. 12) Third party Management (insourcing and outsourcing) conducting third party audit to ensure compliance.13) HA Audits faced such as USFDA, MHRA, WHO, TGA etc.

Profile Summary:1) Dynamic career with more than 15 years of experience in Analytical Quality & compliance department.2) Handling quality operations - Lab investigation, Deviation, Internal audit, CSV, DI, QMS, equipment lifecycle, and documentation activities with strong interpersonal skills.3) Expertise in implementation of laboratory system, lean lab process and data review governance model.4) To ensure the all‐time readiness of site for HA audits / Customer audits.5) Proficient in the implementation of Global standards, Site SOPs, GMP guidelines, QMS tools.6) Attending site LCCB & quality meetings and representing department SPOC during meetings.7) Ensuring quality and compliance at site. Review and Approve GMP documents associated with the GMP activity.8) Review & approval of site apex documents such as Validation master plan/Maintenance master plan (VMP/MMP) and Computer system validation master plan (CSV) etc.9) Ensuring the compliance w.r.t. QMS, GxP and self‐Inspection programs. Having knowledge with practical approach on risk assessment studies, impact assessment studies and investigations10) Pivotal in ensuring that the Instrument/Equipment Calibration, PM, and IQ/OQ/PQ documents and reports meets the quality standards and requirements of the cGMP and regulatory requirements like 21CFR Part11, Eudralex Annex 11, GAMP5.11) Proficient in electronic systems such as Track wise® for Quality records, eLIMS for Reporting data management, eLN for Raw data management, TruVault Veeva for Document management, SUMMIT for training, CisPro for inventory management & ECMMS for LCM of Instruments.12) Experienced in handling the six sigma projects and new laboratory setup with strong knowledge about the lab design & implementation.13) Departmental QIP report preparation, OTJ Trainer, ERT & KAIZEN team member.14) HA Audits faced such as US‐FDA, MHRA, WHO TGA etc.15) Team player with strong communication and problem-solving skills.

1) Awarded by PLATINUM encore award from ADSI for end-to-end responsibility of ATV project.2) Work with AD-SI, participates in scientific discussions, co-define strategies for analytical development projects and other involved functions and facilities3) Work allocation, follow-ups, assign individual work responsibilities, supervises all the activities & accountability.4) Preparation of stability test reports and submitted for regulatory filings.5) Participates in scientific discussions, co-define strategies for analytical development projects and other involved functions and facilities.6) Protocol preparation NDA Batches, CTA Batches, IMPD Batches etc7) Monitoring the personal validation.8) Performs analytical testing of stability samples with proper planning for execution of analysis within window by ensuring RFT and avoiding human errors.9) Software qualification-requalification of instruments.10) Team player with strong Inter-personal skills and ability to work in a multi–cultural environment. Possess a detail-oriented attitude.11) To represent daily conference staff meeting and ensure the work activities and executing tasks as appropriate to the timely accomplishment of objectives.12) Trending of Monthly, Half yearly & annual activity report as in Enterprise lab matrix.13) Backup Support to Calibration Planning, preventive maintenance, service plan and troubleshooting of instruments as per annual calibration schedule.14) Training and Mentoring as an OTJ Trainer.15) Support to lab as KAIZEN team member for continuous improvement.16) Performs data review of stability samples (DS & DP) and release testing.17) Specialist in data integrity, Empower Audit trail review,21 CFR part 11 compliance, Quality Management System, Current Good Laboratories Practices.18) Audit Faced: USFDA

1) Work allocation, follow-up and complete the task with RFT. 2) Preparation of stability test reports and submitted for regulatory filings.3) Participates in scientific discussions, co-define strategies for analytical development projects and other involved functions and facilities.4) Protocol preparation NDA Batches, CTA Batches, IMPD Batches etc5) Monitoring the personal validation.6) Performs analytical testing of stability samples with proper planning for execution of analysis within window by ensuring RFT and avoiding human errors.7) Software qualification-requalification of instruments.8) Team player with strong Inter-personal skills and ability to work in a multi–cultural environment. Possess a detail oriented attitude.

Glenmark Generics Limited:-1) End to end responsibility of stability drug products. Preparation of stability protocol, Charging & pullout of stability sample as per stability protocol.2) Ensure quality and compliance during analytical stability drug testing. Frontline analyst working in shifts to ensure compliance and delivery of projects under the guidance of supervisor.3) Accountable for Management of stability chamber and handling troubleshooting of stability chamber with proper documentation .4) SPOC for stability analytical activity and its timeline completion.5) Frontline analyst working in shifts to ensure compliance and delivery of projects under the guidance of supervisor. 6) Performs analytical testing of stability samples, finish product sample with proper planning for execution of analysis within window by ensuring RFT and avoiding human errors.7) Monitoring of Stability Sample w.r.t reconciliation.8) Initiation of QI and involving investigation and evaluate related impact assessment and proposed CAPA.9) Performing training & quality system as laboratory job functions.

Cipla Limited:- 1) Trained on pharmacopeia method for packaging material like glass vial, aluminum foil, PV, PVC, PVDC, HDPE bottles etc. 2) Parallelly trained for LCM activities and Core team member of life cycle management group. Calibration of instrument and equipment in QC laboratory. 3) Frontline analyst working in shifts to ensure compliance and delivery of projects under the guidance of supervisor. 4) Handled advance technology instruments i.e., XRD, TGA, Particle size Analyzer, Osmometer, IR, NIR, HPLC, UPLC etc. for Instrument related analysis of all QC samples.