Trackwise
SIVA REDDY MARAMREDDY
Senior Quality Assurance Specialist
Hyderabad
Summary
- Highly accomplished and performance-driven Quality Assurance professional with over 11.3 years of experience in the pharmaceutical industry, specializing in Solid Oral Dosage forms and various Quality Functions.
- Demonstrating expertise across a wide range of areas, including Manufacturing, Pharmaceutical Development, Commercial Operations, Product Development, Scale Up and Technology Transfer, IPQA, DQA, Audit & Compliance, QMS, Incident Investigation, OOS & Market Complaints, Validation & Qualification of Equipment and Utilities, and Computer System Validation.
- Proven ability to effectively manage Quality Systems in OSD and Product Development facilities. Recognized for leadership and accountability excellence, fostering cross-functional collaboration and consistently delivering outstanding results.
- Skilled in engaging with regulatory bodies to ensure compliance with internal and statutory standards, playing a pivotal role in upholding quality and regulatory requirements.
- Effective communicator with exceptional relationship management skills, enabling successful collaboration with stakeholders at all levels. Results-oriented mindset and strong analytical abilities drive continuous improvement initiatives. Received prestigious awards, including the Best Quality Team Award, for exemplary performance.
Overview
11
11
years of professional experience
2
2
Certificates
1
1
Language
5
5
years of post-secondary education
Work History
Senior Quality Assurance Specialist
Ferring Laboratories Private Limited
Hyderabad
01.2023 - Current
- Oversaw and led Quality Assurance, Quality Control, and Microbiology in day-to-day operations as alternative Site Quality Representative.
- Led Commissioning, Qualification, and Validation team and Technology Transfer team for Commercial Products, effectively prioritizing activities and projects.
- Developed and established strategies for new facility specializing in Commissioning, Qualification, and Validation of Equipment's and Utilities and Analytical Instruments and Computer System Qualification and Validation.
- Ensured continuous compliance with cGMP practices, regulations, and standards, fulfilling requirements of Ferring Global and regulatory authorities.
- Managed site Quality Management System (QMS) activities for Tech Transfers, Quality Improvement Projects, and Regulatory Compliance in India.
- Identified and implemented continuous improvement initiatives within Quality Management System, enhancing compliance levels and operational efficiency.
- Actively participated in cross-functional meetings to address reported issues and work towards closure of observations.
- Served as Site Coordinator for Track wise, Learning Management System (LMS), and Veeva applications.
- Strategy defined for Analytical Instrument Qualification and Computer System Validation.
- Demonstrated expertise in handling Change Controls, Deviations/CAPA, and Out of Specification (OOS) investigations through Track wise System.
- Conducted cGMP training programs and awareness training for all employees, including LMS personnel.
- Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies
Quality Assurance Specialist
Ferring Laboratories Private Limited
Hyderabad
05.2021 - 12.2022
- Certified ISO 9001:2015 Quality Management Systems Certified and Ferring Lead Auditor, ensuring adherence to quality standards.
- Facilitate internal and external audits, managing responses, tracking, and closure of audit findings.
- Local Regulatory consultant for NOC, Test License, and Manufacturing License.
- Quality Management Compliance Specialist proficient in Fedora and Veeva Electronic Document Management and Track wise Modules Management.
- Implemented Electronic Document Management System and acted as site coordinator, power user, and technical trainer for Veeva Quality Docs.
- Skilled in conducting Phase II Investigations for Out of Specification (OOS) incidents.
- Prepare and review Standard Operating Procedures (SOPs) to ensure smooth functioning of QA and QC processes.
- LMS (Learning Management System) Power User responsible for system administration, training needs identification, training matrix preparations, and coordination of cGMP training implementation.
- Involved in Technology Transfer of Solid Oro Dispersible granules from CMO to FLPL.
- Conducted GAP assessments for process and analytical requirements in Technology Transfer.
- Experienced in executing scale-up processes and reviewing Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR).
Research Associate (Senior Executive)
AET Laboratories Private Limited
Hyderabad
06.2017 - 04.2021
- Experienced in Formulation Development of Generic Solid Oral Dosage forms for regulatory markets.
- Conducted comprehensive literature searches and performed pre-formulation studies to support product development from laboratory scale to pivotal scale.
- Significantly reduced project development timelines by implementing appropriate pre-characterization techniques and employing reverse engineering of reference formulations during development process.
- Implemented alternative sources of APIs (Active Pharmaceutical Ingredients) for generics, resulting in cost-effective formulations.
- Successfully executed exhibit and commercial batches, ensuring smooth manufacturing processes.
- Assisted in addressing queries received from regulatory agencies, demonstrating knowledge of different regulatory aspects, particularly for US and EU markets.
- Worked collaboratively as part of team, maintaining strong coordination with cross-functional departments to ensure successful delivery of products.
Executive
AET Laboratories Private Limited
Hyderabad
07.2016 - 05.2017
- Implemented and managed Quality Management System (QMS), ensuring adherence to quality standards and regulatory requirements.
- Prepared and reviewed Annual Product Quality Reviews (APQRs) to evaluate product quality and identify areas for improvement.
- Conducted qualification assessments of suppliers to ensure their compliance with quality standards and specifications.
- Effectively managed change control and deviations logging processes, ensuring proper documentation and resolution of issues.
- Conducted training programs, including on-the-job training and cGMP (Current Good Manufacturing Practices) training, to enhance employee knowledge and adherence to quality standards.
- Verified dispensing labels and Clinical Batch Processing records for accuracy and compliance.
- Reviewed stability-related documents to monitor and assess product stability over time.
- Successfully established document archival system, ensuring efficient storage and retrieval of critical documents.
- Implemented training programs, including on-the-job training and other cGMP training initiatives, to enhance employee knowledge and ensure compliance with quality standards.
Officer
AET Laboratories Private Limited
Hyderabad
02.2014 - 07.2016
- Responsible for performing In-Process Quality Assurance (IPQA) activities for oral dosage forms in manufacturing and packaging, ensuring compliance with quality standards and maintaining accurate records.
- Implemented Good Manufacturing Practices (GMP) to ensure adherence to quality and regulatory requirements.
- Conducted line clearance activities prior to the startup of various manufacturing operations, ensuring cleanliness and readiness of the production line.
- Reviewed and coordinated GMP activities, including Batch Manufacturing and Packing Records, In-process Quality Control records, Certificate of Analysis (COAs), and other relevant batch records, as well as deviation and investigation reports.
- Reviewed quality records of other departments to ensure compliance with quality standards and identify areas for improvement.
- Managed the issuance, retrieval, and archival of documents, ensuring proper documentation control and traceability.
- Prepared, reviewed, and issued Standard Operating Procedures (SOPs) to guide employees in performing their duties according to established processes and quality standards.
Executive
Sharma Pharmaceuticals Private Limited
Vadodara
08.2012 - 12.2013
- Successfully executed business development strategies and implemented sales forecasts in South Zone, resulting in increased market presence and revenue growth.
- Established strong foothold in orthopedic devices sector in South Zone by fostering strong relationships with doctors and network partners.
- Built and maintained robust network of healthcare professionals, key opinion leaders, and distribution channels to expand market reach and maximize sales opportunities.
- Conducted market research and analysis to identify emerging trends, customer needs, and competitive landscape, providing valuable insights for strategic decision-making.
- Collaborated with cross-functional teams, including marketing, product development, and operations, to drive product awareness, develop innovative solutions, and ensure customer satisfaction.
- Proactively engaged with customers, understanding their requirements and offering tailored solutions to meet their specific needs.
- Monitored market dynamics, competitor activities, and regulatory changes to adjust sales strategies and capitalize on new opportunities.
- Achieved and exceeded sales targets, contributing to overall business growth and profitability.
Education
Masters - Pharmaceutical Sciences
05.2010 - 05.2012
GPA 83.00
Bachelor of Pharmacy - Pharmacy
06.2006 - 05.2010
GPA: 78.00
High School Diploma -
03.2004 - 04.2006
GPA:87.80%
High School Diploma -
03.2003 - 04.2004
GPA:91.10 %
Skills
Commissioning , Qualification and Validation
Product Development and Technology Transfer
Computer System Validation
Audits and Compliance
Sound quality management techniques
Change Management Systems
Deviation and CAPA Management System
Accomplishments
- Played a key role in the establishment of New Solid Oral Dosage forms and the implementation of a Quality Management system in accordance with Ferring global standards.
- Led the commissioning, qualification, and validation efforts for equipment, analytical instruments, and utilities at the new facility, ensuring compliance with regulatory requirements and industry best practices.
- Made significant contributions to international regulatory audits, including EU GMP, USFDA, and Russian Health Regulatory divisions, by ensuring compliance with applicable regulations and successfully addressing audit findings.
- Spearheaded the establishment of electronic data management systems and Quality Management systems, enhancing data integrity, documentation control, and overall efficiency.
- Finalized the Commissioning, Qualification, and Validation (CQV) strategy for the expansion project, assuming the role of project lead and overseeing all related activities.
Software
Veeva Quality Docs Management
Service Now
Coupa
Navision
Learning Management System
Microsoft Office Tools
Certification
CQI (Chartered Quality Institute) and IRCA (International Register of Certificated Auditors) Certified ISO 9001:2015 Lead Auditor Training course by BSI Training Academy
Timeline
Lean Principles in Operation Management
07-2023
Senior Quality Assurance Specialist - Ferring Laboratories Private Limited
01.2023 - Current
Quality Assurance Specialist - Ferring Laboratories Private Limited
05.2021 - 12.2022
Research Associate (Senior Executive) - AET Laboratories Private Limited
06.2017 - 04.2021
Executive - AET Laboratories Private Limited
07.2016 - 05.2017
Officer - AET Laboratories Private Limited
02.2014 - 07.2016
Executive - Sharma Pharmaceuticals Private Limited
08.2012 - 12.2013
Jawaharlal Nehru Technological University Kakinada - Masters, Pharmaceutical Sciences
05.2010 - 05.2012
ACHARYA NAGARJUNA UNIVERSITY - Bachelor of Pharmacy, Pharmacy
06.2006 - 05.2010
Sri Chaitanya Junior College - High School Diploma,
03.2004 - 04.2006
Alpha Public School - High School Diploma,
03.2003 - 04.2004