SrinivasaRao J
Hyderabad,TG
Summary
Quality professional with 22+ years of progressive experience with sound knowledge in Quality Assurance, Quality Control, and Analytical Research and Development functions. Expertise in product non-conformance investigations, deviations, CAPA's, Change management, CMO management, Vendor audits, facility audits and Quality document management. Process validation of Solid, Liquid, Nasal Sprays, Ointments, Gels, Transdermal and sterile (small volume parenteral) dosage forms. To perform analytical investigations and analytical problem solving, in support of formulation development activities and supervise the day to day analytical development activities and the analytical development team; Skilled in securing compliance with regulations such as GMP's, GLP's and Quality System (21 CFR 820.180). I Possess expertise with FDA, ICH, and EU requirements for pharmaceutical, drug substance, drug product testing. I collaborate effectively with outside vendors and internal groups including development, manufacturing, quality assurance and product development.
Overview
22
22
years of professional experience
Work History
Manager – Quality & Regulatory Affairs
Salicylates and Chemicals pvt ltd
09.2022
- Ensuring that products meet all relevant regulatory requirements set by governing bodies such as the FDA, EMA, or other regulatory agencies in different countries
- Developing, implementing, and maintaining quality management systems to ensure compliance with quality standards such as ISO 9001, ISO 13485, or other relevant regulations
- Implementing and maintaining quality assurance processes to monitor and evaluate the quality of products and processes at various stages of development and production
- Preparing and submitting regulatory documents, such as product registrations, submissions for marketing authorizations, and other regulatory filings required for product approval
- Conducting risk assessments and implementing risk management strategies to identify and mitigate potential risks associated with products or processes
- Coordinating and participating in internal and external audits and inspections to ensure compliance with regulatory requirements and quality standards
- Managing changes to products or processes and ensuring that changes are implemented in compliance with regulatory requirements and quality standards
- Ensuring that product labeling and packaging comply with regulatory requirements and standards, including content, format, and language requirements
- Monitoring and reporting on the safety and performance of marketed products, including handling complaints, adverse events reporting, and conducting post-market surveillance activities
- Providing training and education to employees on quality and regulatory requirements, standards, and best practices to ensure compliance throughout the organization
- Maintaining accurate and up-to-date documentation and records related to quality and regulatory activities, including product registrations, submissions, and audit reports
- Identifying opportunities for process improvement, implementing best practices, and driving continuous improvement initiatives to enhance quality and regulatory compliance within the organization.
Manager – Quality Assurance / Quality Control
SM Pharmaceuticals SDN BHD
12.2017 - 09.2022
- Leading a Team of 45 QA/QC Executives/Officers, 02 Plant QA/QC Asst
- Managers, along with 5 Nos Implementation of on-line inspection system, procedures and maintaining all stipulated optimum systems and 6 Nos for Conducting of internal quality audits in the organization to fulfill contract manufacturing requirement
- Providing on site direction for site QMS to ensure compliance with cGMP, QSR, ISO, MHRA USFDA, MHRA, MCC, TGA, ANVISA, EU and JPAL for terminally sterilized and aseptically filled small volume parenterals and sterile medical devices (diagnostic and therapeutic)
- Implementation of regularity approvals in Personnel Hygiene System, ISO 9001 (QMS), ISO 14000 (EMS), and WHO-GMP under Schedule M, H, T (in accordance with Drug & Cosmetics Act)
- Implementation of product release system as per cGLP, cGMP, cGDP
- New Research and development activities Technology transfer, Scale Up Batch, Validation & Commercial related to ADL
- Commissioning, Validation & verification qualification as per IQ, OQ, DQ, PQ of all Laboratory equipment’s and plant machinery
- Process & product Validation of Injectables, Tablet, capsules & Liquid syrups
- Preparation of Site Master File, Master Batch Records, Updation of BMR, BPR, MBR and GMP files
- Review, Release & Approval of Art works of Unit cartons, Labels, Stiffeners, Wrapper, Shipper, Aluminum Foils, Glass vials, Ampoules, HDPE bottle & caps etc
- Co-ordination with R&D for Validation, Exhibit batches of our own new product
- To set up the in process Quality checks at every level of Process and Audit system
- Leading Total Quality Assurance and establishment of Quality control tools
- Coordinate for all Quality activities of QA at HO like planning, IPQA, packaging, Handling of Market complaints, Product Recalls, and their change control to avoid future occurrence
- Establishment of Quality Assurance facility and procurement of regulated inspection for new facility, Validations –Analytical Method validation, Analytical method transfers activity
- Equipment and instrument validation protocol approval and certification, Review and approval of protocol and summary reports of compatibility study
- Research, Development, and Implementation though Training, wholly responsible for Designing & Implementing / ensuring Compliance to Quality, Validation System & Analytical Assurance as per WHO-GMP & all International Guidelines
- Attending Regulatory and customer audits, Technical agreements review, Review of ANDA filing.
Head – Quality and Analytical operations
Salicylates and Chemicals pvt ltd
05.2014 - 12.2017
- Managed a group of 25 members
- Ensuring that Quality systems are in place and are effectively managed (CAPA, Deviations, Change Control, Complaints, SOPs, Audit program, Quality Investigation)
- Manage the QA/QC team, allocating and controlling workflow
- Devising and establishing a company’s procedures, standards and specifications
- Development, periodic review, revision and implementation of SOPs as required
- Defining quality procedures in conjunction with operating staff
- Setting up and maintaining controls and documentation procedures
- Making suggestions for changes and improvement and how to implement them
- Handling of product complaints
- Annual product review and review of stability reports
- Liaising with customers and regulatory authorities regarding quality matters, including hosting inspections and responding to observations
- Periodic GMP training for relevant staff
- Checking /monitoring of instruments calibration and their records
- Change control management
- Monitoring of stability study
- Quality rick management
- Validation & qualification of facility & equipment
- Addressing the OOS (Out of Specifications) Laboratory incidents (Quality impacting as well as Non-impacting) Deviations
- Responsible for writing and updating SOP's and analytical test methods
- Major activities involve Planning and Releasing of In-process, Finished product Samples and Stability samples of Exhibit batches
- Responsible for Compliance to system SOPs, cGLP, cGMP, FDA and other regulatory requirements and ensuring compliance with all company policies and procedures.
Manager - Analytical Research and Development
Adcock Ingram Ltd
09.2011 - 08.2014
- Managed a group of 18 analysts
- Developed and performed several method validations and transfers for drug substances and products for CMC submissions of ANDA's
- Analyzing a formulation development and stability sample which involves critical evaluation of following product parameters
- Studying the In-Vitro dissolution profiles of the development samples
- Training the trainee officers and staff in instrumental SOP's, STP's and System SOP's
- Preparation of validation protocols, Reports, and summary reports
- Addressing the OOS (Out of Specifications) Laboratory incidents (Quality impacting as well as Non-impacting) Deviations
- Responsible for writing and updating SOP's and analytical test methods
- Major activities involve Planning and Releasing of In-process, Finished product Samples and Stability samples of Exhibit batches, Commercial batches, and Validation batches in Quality Control Department
- Responsible for Compliance to system SOPs, cGLP, cGMP, FDA, and other regulatory requirements; ensuring compliance with all company policies and procedures
- Developed and validated analytical and QC methods for drug product and drug substance characterization
- RP-HPLC, Size Exclusion Chromatography, Ion-Exchange Chromatography.
Scientist III – Reference Standards Laboratory
United States of Pharmacopeia
07.2006 - 08.2011
- Analysis of samples received from industries and research scholars using HPLC and GC
- Looked after the standardization of analytical methods for industrial clients
- Proven ability to investigate complex failures and provide scientific justification; well versed with Reference standards qualification and Analytical development function
- Competently perform routine analytical test procedures and operate standard analytical instruments (eg HPLC, GC/LC-MS, FTIR, NMR, UV /VIS etc..)
- Ensure calibration / verification of equipment at laboratory situated in the focus factory by inclusion of all test equipment in the Check List of Lab Equipment Calibration /Verification
- Ensure that the calibration/verification of analytical instruments, the use of certified analytical reference standards and the maintenance of the equipment are established and followed, prior use of equipment
- Ensure annual Performance Qualification (PQ) of the analytical instruments are completed and followed prior use in analyses
- Understand and the use of basic safety equipment and instructions, precautions in handling reagents and disposal of chemical waste according to local environmental regulations
- Ensure the data is provided timeously for the monthly generation of statistical control charts to trend test results on the shared drive.
Executive – Unit III, Quality Control
Aurobindo Pharma Limited
09.2000 - 08.2004
- Developed, validated and transferred HPLC, GC, PSD and Dissolution methods
- Maintained the records of test data in conformance with the company and regulatory policies
- Responsible for supporting product development department by analyzing In-Vitro Dissolution profiles, samples from pre-formulation studies, product development and optimization studies and accelerated stability studies
- Organized cGLP & Technical Training Programs for continuous improvement for all scientists of analytical department
- Prepared SOPs, GTPs, STPs, method validation and transfer protocols and reports
- Supported regulatory department by providing Validation documents and other documents required for the regulatory submissions and queries from various regulatory agencies such as FDA, MCA and MCC.
Education
Doctor of Philosophy - Pharmaceutical analysis
Acharya Nagarjuna University
Andhra Pradesh, India12.2021
Master of philosophy - Pharmaceutical analysis
Acharya Nagarjuna University
Andhra Pradesh, India10.2010
Master of Pharmacy - Pharmacology
Annamalai University
Chidambaram, India07.2006
Bachelor of Pharmacy - undefined
Gulbarga University
Gulbarga, India06.2000
Intermediate (10+2) - undefined
Board of Intermediate Education
Hyderabad, India03.1995
10th Class - undefined
Board of Secondary Education
Hyderabad, India03.1993
Skills
- Quality Management (QC & QA)
- CAPA
- Change Control
- Hazard Analysis Critical Control Points
- FMEA
- Process and Equipment Validation
- Computer System Validation
- Internal and External Auditing
- Customer Complaint Resolution
- Technical Writing
- OOS/OOT/Incident Investigations
- Decision-making
Regulatory And Audits
Excellent supervisory skills and team oriented with US-FDA, NPRA, MCC, MHRA, TGA, ICH, EU, NPRA and OSHA, Asean guideline requirements for pharmaceutical, drug substance, drug product and device testing.
Technical Competence
Facilitated field action team and process to ensure successful execution through customer notification and documentation needed for timely ANDA/NPRA Drug Product Dossier’s submission. Coordinated auditor selection, policy, and procedure & instruction preparation, implemented, and conducted document control and internal audits. Identify opportunities for improvement through review and analysis of quality indicators, data analysis, internal audits, and customer satisfaction surveys. Managed completed Batch Records and supporting documentation review activities required for product disposition.
Personal Information
IC Number: S9865744
Timeline
Manager – Quality & Regulatory Affairs
Salicylates and Chemicals pvt ltd
09.2022
Manager – Quality Assurance / Quality Control
SM Pharmaceuticals SDN BHD
12.2017 - 09.2022
Head – Quality and Analytical operations
Salicylates and Chemicals pvt ltd
05.2014 - 12.2017
Manager - Analytical Research and Development
Adcock Ingram Ltd
09.2011 - 08.2014
Scientist III – Reference Standards Laboratory
United States of Pharmacopeia
07.2006 - 08.2011
Executive – Unit III, Quality Control
Aurobindo Pharma Limited
09.2000 - 08.2004
Doctor of Philosophy - Pharmaceutical analysis
Acharya Nagarjuna University
Master of philosophy - Pharmaceutical analysis
Acharya Nagarjuna University
Master of Pharmacy - Pharmacology
Annamalai University
Bachelor of Pharmacy - undefined
Gulbarga University
Intermediate (10+2) - undefined
Board of Intermediate Education
10th Class - undefined
Board of Secondary Education
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