Job Search Status
Open to workDesired start date: 2 weeks notice
Open To Work
Viswateja Bollapragada
Hyderabad
Work Preference
Summary
Dynamic quality management professional with extensive experience at Promea Therapeutics, excelling in CAPA investigations and compliance with cGMP standards. Proven leadership in managing QMS activities and analytical methods, coupled with strong problem-solving skills. Committed to enhancing operational excellence and ensuring regulatory adherence in pharmaceutical processes.
Overview
12
12
years of professional experience
Work History
Dy.Manager
Promea Therapeutics
Hyderabad
09.2020 - 03.2025
- Conducted routine and non-routine analyses of in-process materials and finished goods for diagnostic products.
- Ensured compliance with QMS through GLP and FG team oversight for timely product release.
- Investigated out-of-specification results, market complaints, and deviations to implement effective CAPA.
- Managed CGMP compliance across validation, stability sections, and quality-related aspects.
- Reviewed and approved CAPA plans, including effectiveness checks to ensure ongoing compliance.
- Maintained knowledge of current GxP regulations and auditing techniques to enhance operational standards.
- Monitored implementation of pharmacopeial changes as per IP/BP/USP/EP/JP guidelines.
- Performed analytical testing on plasma-derived products using validated methods, adhering to CGMP standards.
- Oversaw quality assurance processes for manufacturing operations in a fast-paced environment.
- Developed and implemented quality control policies and procedures for production teams.
Senior Executive-QMS
Recipharma Pvt Ltd
Bangalore
01.2019 - 09.2020
- Good understanding of Pharmaceutical processes, SOP's, STP's, Analytical methods and reports, Review of SOPs, STPs (RM/PM) and Specifications.
- Working Knowledge of 21 CFR part 11 compliance and data integrity.
- Excellent knowledge of cGMP, ICH and other regulatory requirements.
- Handling QMS activities like deviations, change controls & lab incidents.
- Excellent problem solving, analytical and troubleshooting skills.
- Participation and Cooperation with internal and external regulatory audits.
- R&D Analytical Protocol and Reports Preparation, Analytical New product development.
- Organize and support Project Leader in managing internal study team and customer meetings.
- Instrument management (All QC lab instruments) and Inventory management in LIMS (Columns, Standards, Chemicals, Reagents and Volumetric solutions).
- Prepare correspondence, including meeting minutes, for study team and/or customer. Assist project sub-team leads in defining resource requirements, utilizes systems in order to monitor status.
Senior Executive-Project
Syngene international Ltd
Bangalore
08.2015 - 01.2019
- Coordinate project schedules, estimates, cost control, risk management activities.
- Vendor Management once agreement is signed and approved. Coordinate with third party vendors.
- Work experience in testing of IP, FP and RM samples.
- Follow-up with vendors for day to day operations and monitor the status of final invoices.
- Overview of materials availability for R&D operations.
- Implementing change order control processes.
- Ensure Project Leader has timely and accurate data on areas including cost, schedule, scope, utilization, change orders, quality to support better decision-making.
- Preparing presentation materials including study data for internal study team and customer meetings.
- Working Knowledge of 21 CFR part 11 compliance and data integrity.
- To coordinate for cGMP/ cGDP related training to all employees of QC department.
- Participation and Cooperation with internal and external regulatory audits.
Officer-I
Medreich Pvt Ltd
Bangalore
08.2014 - 08.2015
- Monitor stability chambers and chart recorders on a daily basis.
- To ensure timely analysis of stability samples.
- Stability Chamber Monitoring and Maintenance.
- Stability sample requirement, develop stability protocols.
- Performing routine QC Stability testing of all active substances, excipients, finished dosage forms and complaint samples.
- Capable of independently troubleshooting analytical and instrument problems.
- Assist with compilation of QC laboratory documentation metrics.
- Exposure to Internal/External audits.
- Knowledge on Calibration of Analytical instruments.
Tr.chemist
Lee Pharma Limited
Visakhapatnam
01.2013 - 05.2014
- Maintaining Good Laboratory Practices.
- Work experience in testing of IP, FP and RM samples.
- Receiving samples for testing and testing the samples as per specification.
- Ensure work environment is clean and safe complying with safety and pharmaceutical regulations.
- Adherence to cGMP & quality standards.
- Troubleshooting and maintenance of various instruments.
Education
Master of Pharmacy - Pharmacology & Clinical studies
GITAM university
Visakhapatnam01-2013
Skills
- ISO 13485:2016 Certified IA
- ISO 9001
- Infusion Therapis
- Akta Pure
- DGI Approved Chemist
- Method Verification & Validation
- MDR 2017/745
- ICH-GCP
- GMP
- GLP
- Handling QMS Activities
- CAPA investigation
- Analytical instruments
- LIMS
- SAS
- SAP
- MS-office
- Six sigma
- Leadership
- Planning and organisation
- Team skills
- Elsia Rapid RT-pCR
- Biochemistry
- Plasma Products
Publications
In Vivo Analgesic Activity of Petroleum Ether Extract of Boswellia Ovalifoliolata Linn Leaves, Viswateja B, Venkatesh B., 2011
References
- Gokul Ram, 9686825718
- Nagabhushanam, 9650411660
Languages
- Hindi
- Telugu
- English, Full Professional Proficiency
- Hindi, Full Professional Proficiency
- Telugu, Full Professional Proficiency
Honor Awards
Credit of the team being selected for an Award in Mar'18 as per the client feedback., 03/18, Syngene international
Timeline
Dy.Manager
Promea Therapeutics
09.2020 - 03.2025
Senior Executive-QMS
Recipharma Pvt Ltd
01.2019 - 09.2020
Senior Executive-Project
Syngene international Ltd
08.2015 - 01.2019
Officer-I
Medreich Pvt Ltd
08.2014 - 08.2015
Tr.chemist
Lee Pharma Limited
01.2013 - 05.2014
Master of Pharmacy - Pharmacology & Clinical studies
GITAM university