Srikant Reddy
Saco,USA
Summary
Results-driven pharmaceutical professional with 10+ years of experience in Academics, Quality Assurance, and bio-equivalent studies, highly skilled in managing and executing projects, ensuring adherence to protocols and regulatory standards. Proficient in monitoring studies to minimize errors and maintain data integrity. Strong ability to collect samples, conduct analysis, and draw meaningful conclusions. Collaborative and effective communicator with expertise in working with ethical committees to ensure compliance with guidelines. Demonstrates exceptional teamwork, organization, and commitment to upholding the highest standards of quality and ethics in pharmaceutical research. Quality Assurance professional with experience in ensuring product excellence and compliance. Strong focus on team collaboration and achieving results, adaptable to changing needs. Skilled in quality control processes, problem-solving, and maintaining high standards. Known for reliability and effective communication.
Overview
12
12
years of professional experience
1
1
Certification
Work History
Quality Assurance Associate
Abbott Inc
07.2024 - Current
- Perform tests on packaging to verify its integrity, durability, and compliance with regulatory requirements
- Document inspection results and communicate findings to the appropriate teams
- Maintain accurate and detailed records of all quality assurance activities, including test results, inspections, and any deviations from standards
- Ensure that all documentation complies with regulatory requirements and company policies
- Ensure that packaging processes comply with relevant industry regulations (e.g., FDA, ISO standards) and internal quality standards
- Assist in preparing for and participating in audits conducted by regulatory bodies or internal auditors
- Monitor packaging processes to identify areas where quality issues may arise
- Participate in continuous improvement initiatives aimed at enhancing packaging quality and efficiency
- Provide feedback to production teams to help improve packaging practices and prevent recurring issues
- Identify and report non-conforming packaging materials or processes
- Assist in root cause analysis and implement corrective and preventive actions (CAPA) to address non-conformities
- Follow up on CAPA to ensure issues are resolved effectively
- Work closely with production, engineering, and regulatory teams to ensure packaging processes meet quality standards
- Communicate any quality-related issues to relevant stakeholders and collaborate on finding solutions
- Provide support during investigations of quality issues related to packaging
- Assist in the training of production staff on quality standards and proper packaging procedures
- Stay current on industry best practices, regulatory changes, and new technologies related to medical device packaging
- Collaborate with suppliers to ensure that packaging materials meet quality requirements
- Participate in supplier audits and assessments to verify compliance with quality standards
Quality Assurance Specialist
Pharmacare
04.2020 - 08.2022
- Company Overview: Pharmaceutical company in Vijayawada, India
- Created, documented, and maintained quality assurance protocols and standard operating procedures (SOPs) to ensure consistent manufacturing and compliance with regulatory standards
- Performed testing and validation of liquid oral preparations to verify product quality, adhering to GMP guidelines
- Gathered and analyzed quality-related data from production processes, identifying trends and potential risks to maintain high product standards
- Assisted in internal audits, preparing required documentation and ensuring compliance with regulatory bodies such as FDA and local authorities
- Participated in cross-functional teams to implement continuous improvement initiatives, enhancing quality control processes and production efficiency
- Monitored adherence to regulatory requirements, including cGMP, FDA, and local pharmaceutical laws, ensuring all processes met legal standards
- Managed and resolved customer complaints by investigating issues, collaborating with relevant departments, and implementing corrective actions to prevent future occurrences
- Conducted risk assessments on production processes, identifying potential quality issues and suggesting preventive measures
- Collaborated with suppliers to ensure raw materials met quality specifications, establishing and maintaining supplier quality agreements
- Developed and conducted quality training programs for new employees, ensuring proper understanding and implementation of quality assurance procedures
- Maintained accurate and up-to-date quality assurance records, including deviations, corrective and preventive actions (CAPAs), and batch records, ensuring traceability and transparency in production
- Pharmaceutical company in Vijayawada, India
HOD Pharmacology
Yalamarty Pharmacy College
06.2017 - 03.2020
- Member of Institutional planning, development, and skill education
- Member internal quality assessment cell for University Accreditation
- Operations head of the Quality Control microbiology testing function
- EM monitoring and utility sampling
- Maintenance of SOPs and documentation for instruments
- Protocol development for sterilizing labs and maintaining aseptic conditions
- Experience in conducting a literature review and good documentation practices
- Contributing to scientific literature through literature reviews, manuscript writing, and presenting study findings at scientific conferences or meetings
- Project management responsibilities for preclinical trials
- Overseeing multiple aspects of the study, including timelines, resources, budgeting, and coordinating activities among different stakeholders
Assistant Professor/Principal
Lydia College of Pharmacy
11.2012 - 06.2017
- Demonstrated expertise in delivering engaging lectures, grading assignments, and organizing course materials per the approved pharmaceutical sciences curriculum
- Led the Medication Therapy Management (MTM) program, overseeing the analysis of patient medication profiles and ensuring optimal treatment outcomes
- Proven excellence in performance and industry knowledge led to promotion to the position of Principal, assuming additional responsibilities
- Gained significant exposure to the pharmaceutical industry through interactions with patients, doctors, and professors
- Ensure compliance with the study protocol, Good Clinical Practice (GCP) guidelines, and applicable regulatory requirements
- Overseeing the collection, documentation, and verification of clinical trial data
- Ensuring accuracy, completeness, and timeliness of data entry and resolving data discrepancies or issues as needed
- Collaborating with data management teams to ensure data integrity
Education
M.S - Drug Regulatory Affairs
Northeastern University
Boston, MA03.2024
Master’s - pharmacology
Andhra University
09.2012
Skills
- Pharmaceutical Sciences
- Compliance with cGMP
- Clinical Research
- Bio-Equivalent Studies
- Study Management
- Protocol Adherence
- Regulatory Compliance
- Data Integrity
- Sample Collection and Analysis
- Ethical Guidelines
- Teamwork and Collaboration
- Effective Communication
- Organizational Skills
- High Attention to Detail
- Problem-Solving
- Regulatory writing
- MS Planner/Project
- MS Office (Data handling and graphs)
- SharePoint
- Windows
- Mac IOS
- Decision-making
- Team leadership
- Mentoring
- ISO Standards
- Raw Material Inspection
- Packaging Specifications
- Validation Techniques
- Problem-solving skills
- Team Collaboration
- Inspections
- Sampling
- Six Sigma Methodologies
- Batch Production Records
- Surface Swab Tests
- Production Line Audit
- Software testing
- Team Leadership
- Decision-Making
- Internal Audits
- Safety Procedures
- Quality improvements
- Quality Management Systems
- Analytical Thinking
- Agile Methodology
- Quality Assurance
- Project Management
- Finished Product Inspection
- External Audits
- Establishing and Enforcing Policy
- Adaptability and Flexibility
- Quality Issue Identification
- Critical Thinking
- Audit reports
- Standards Interpretation
- Correction action planning
Certification
- Risk Management Professional Certification (PMI-RMP®) – Project Management Institute.
- ISO 9001, 2015 Lead Auditor Certification - Exemplar Global or similar.
- Good laboratory practice(GLP)-FDA recognized provider.
Languages
English
Full Professional
Timeline
Quality Assurance Associate
Abbott Inc
07.2024 - Current
Quality Assurance Specialist
Pharmacare
04.2020 - 08.2022
HOD Pharmacology
Yalamarty Pharmacy College
06.2017 - 03.2020
Assistant Professor/Principal
Lydia College of Pharmacy
11.2012 - 06.2017
Master’s - pharmacology
Andhra University
M.S - Drug Regulatory Affairs
Northeastern University
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