GURURAJRAO R
Bangalore
Summary
Results-oriented Quality Assurance Specialist with 19+ years of experience ensuring compliance with quality standards and driving continuous improvement across manufacturing and pharmaceutical industries. Skilled in leading cross-functional teams, implementing robust quality management systems, and resolving complex quality issues. Demonstrated expertise in root cause analysis, statistical process control, and process improvement. Proven track record of achieving significant improvements in product quality, customer satisfaction, and defect reduction. Passionate about driving excellence through a customer-centric approach and fostering a culture of continuous improvement.
Overview
20
20
years of professional experience
Work History
QA Deputy Manager
Syngene International Limited
10.2019 - Current
- Responsible for implementing and enforcing the compliance of the quality systems in place
- Responsible for all QA related stability operations and coordinate with stability team for completion of the activity
- Review and approval of master and executed batch records
- Review and approval of calibration reports (Vendor service reports)
- Facilitate training for new employees, training to existing personnel based on new/ SOP updates, as well as the Annual GMP review across the company.( As a training Co-ordinator)
- Review and approval of the Standard Operating Procedures (SOPs in EDMS), to meet the regulatory requirements as well as the Quality systems
- Participate in quality improvement teams to reduce defects and quality issues and other projects required by management
- Handling of QMS (Deviations, Change controls and CAPA’s)
- Participate in internal departmental audits as well as outside vendor / Clients audits
- Handling of audits (Regulatory and Clients) and responses for observations
- Perform GAP reviews on SOPs to bring all documents to a stage of compliance of documents and processes
- Documentation control and issuance
- Preparation, Review and approval of the URS,FDS,FRA,IQ,OQ and PQ documents
- Coordinating and supporting to all GMP departments for completion of the activities(Archival, Retrieval and Re-archival of the documents)
- Coordinating and supporting to all GMP departments for internal, external and regulatory audits (Arrangement of required documents)
- Coordinating with external documents storage service provider (like Iron mountain and Writers).
QA Team Leader
MYLAN LABORATORIES LIMITED (SPD) (Sterile)
09.2014 - 10.2019
- Preparation and review of Annual Product Quality Review(APQR)
- Preparation, Review and approve of the Standard Operating Procedures (SOPs in EDMS), to meet the regulatory requirements as well as the Quality systems
- Preparation and issuance of the BMR’s and BPR’s
- Coordinating with RA department and provide the documents as per their requirements etc
- Audit preparations for the Regulatory (Ex: MHRA
- USFDA ,MCC, AGES, Canada and TGA) and Customers
- Co-coordinating with R & D and Production of in compilation of Master BMR
- Issue and withdrawal SOP’S and maintaining records for the same
- Issue, Completion, Review and Retrieval of all QC, production and Engineering related documents and log books
- Coordinating with external documents storage service provider (like Iron mountain)
- Preparation and review of the GAP assessment
- Co-ordination to maintain records on destruction of documents (where applicable)
- In process checks and line clearance for all activities (Dispensing, Sterilization, manufacturing, Filling, Capping, Visual inspection and packing).
Assistant Manager (Production –Validation and Documentation )
WINTAC LTD (Sterile)
02.2013 - 09.2014
- Preparation of validation Protocols and Reports for the existing and new equipments
- Preparation of equipment qualification Protocols and Reports for the new equipments
- Preparation of validation calendar and SOP for the new equipments
- Handling of change control, deviations and incidents
- Co-coordinating with R & D , Production and QC for the compilation of validation documents
- Co-coordinating with Regulatory department for the submission of documents to the USFDA
- Supporting for HVAC, Water for injection, Purified water , nitrogen and compressed qualification activities completion.
QA Sr. Executive (IPQA & AQA incharge)
MICRO LABS LTD Eye Drops (Sterile)
06.2009 - 02.2013
- In process checks and line clearance for all activities (Dispensing, Sterilization, manufacturing, Filling, Capping, Visual inspection and packing)
- Supervising the execution activities and completion of records
- Review of the BMR’s and BPR’s
- Reporting and review of any non conformances (Deviations, Incidents etc.) to QA head
- Issue, Completion, Review and Retrieval of trial, Validation and commercial Batch records
- Certification of export product labels against consignee details / Export order
- Co-coordinating with Quality Control to ensure in-process checks (where applicable) is completed before further processing of batch
- Creation, Approval and Issue of Master Protocol / Report for Process Validation
- Issue, Completion, Review and Retrieval of (Domestic and ANDA) Specifications, AWR’S of Raw material, Packing material, In process, Finish and Shelf life products
- Preparation and Reviewing of stability protocol and reports
- Reporting and review of any OOS/OOT, change control to QA head .Investigation and reviewing of market complaints
- Review of COA’s(Raw & Packing materials, Finished products) and stability product reports
- Supporting for Technology transfer/product transfer and Cleaning validation activities.
QA Sr. Executive
Kumar Organic Products LTD (API)
01.2009 - 06.2009
- Review of the BMR’s and BPR’s
- Reporting and review of any non conformances (Deviations, Incidents etc.) to QA head
- Issue, Completion, Review and Retrieval of trial, Validation and commercial Batch records
- Certification of export product labels against consignee details / Export order.
QA Management Staff
CIPLA LTD (API)
02.2008 - 09.2008
- Co-coordinating with Quality Control to ensure in-process checks (where applicable) is completed before further processing of batch
- In process checks and line clearance for all activities
- Review of the BMR’s and BPR’s
- Preparation and review of Annual Product Quality Review(APQR).
QA/QC- Sr.Executive
M/s ChemLab (P) Ltd (Leonid Chemicals)
02.2007 - 01.2008
- Preparation and Review of the Specifications
- Calibration of equipments
- Analysis of raw materials.
QC/QA-Chemist
M/s Meyer Healthcare (P) Ltd
07.2004 - 12.2006
- Preparation and Review of the Specifications
- All availability of laboratory Instrument Operation, Calibration and Documentation
- Preparation and Review of BMR’s and BPR’s
- Batch release
- In process checks and line clearance for all activities (Dispensing, , manufacturing, Blending, compression, Coating, Visual inspection and packing)
- Coordinating with other departments for completion of all GMP activities
- Analysis of Raw materials ,Packing materials and finished products
- Preparation of Laboratory reference standards, reagents and volumetric standard solution Raw materials specifications, Bulk / Finished product specifications, Calibration procedure for laboratory instruments, & glassware and Sop’s etc.
Education
Master of Science - Industrial Chemistry
Gulbarga University Gulbarga
Gulbarga04.2001
Skills
- Quality Management Systems (QMS)
- Good Manufacturing Practices (GMP)
- Regulatory Compliance
- SOP Development and Implementation
- Risk Assessment and Management
- Audit Preparation and Management
- Change Control Management
- Root Cause Analysis and CAPA
- Team Leadership and Development
- Excellent Communication and Interpersonal Skills
- Continuous Improvement
- Document management
- ERP: Enterprise Resource Planning
- Knowledge of SAP
- Knowledge of LIMS
- Knowledge of Trackwise
- Knowledge of LMS
- Knowledge of DCM and D2 system
- Basic Knowledge of CSV
Languages
English, Kannada & Hindi
Audit Faced
- Regulatory - GMP-MHRA, USFDA, MCC, AGES, EMA, TGA and Health Canada
- Customer - Inno Pharma (Alogen Pharma-USA), Bausch and Lomb, Uganda, Kenya, Brazil (Lenomid), Sudan, Sandoz…etc and others like IDMA, ISO and local FDA..etc
- Internal Quality Audits, Self Inspection (QA, QC & Production)
- Involve in the preparation of audit response
Personal Information
- Father's Name: Pralhad Rao. R
- Date of Birth: 09/16/1978
- Marital Status: Married
Educational Qualification
M.Sc in Industrial Chemistry from Gulbarga University
Disclaimer
I hope in all sincerity that on the strength of my potential I will do my best if given an opportunity. I affirm that the above said information is true to the best of my knowledge.
Timeline
QA Deputy Manager
Syngene International Limited
10.2019 - Current
QA Team Leader
MYLAN LABORATORIES LIMITED (SPD) (Sterile)
09.2014 - 10.2019
Assistant Manager (Production –Validation and Documentation )
WINTAC LTD (Sterile)
02.2013 - 09.2014
QA Sr. Executive (IPQA & AQA incharge)
MICRO LABS LTD Eye Drops (Sterile)
06.2009 - 02.2013
QA Sr. Executive
Kumar Organic Products LTD (API)
01.2009 - 06.2009
QA Management Staff
CIPLA LTD (API)
02.2008 - 09.2008
QA/QC- Sr.Executive
M/s ChemLab (P) Ltd (Leonid Chemicals)
02.2007 - 01.2008
QC/QA-Chemist
M/s Meyer Healthcare (P) Ltd
07.2004 - 12.2006
Master of Science - Industrial Chemistry
Gulbarga University Gulbarga
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