SUNAINA KANWAR
Quality Assurance Specialist
Galt,CA
Summary
Quality Assurance professional with over 6+ years of experience in Quality Assurance and Quality Control, specializing in GMP/GLP regulations and SAP software. Key achievements include being selected as a gold tier member of the President's Club and receiving the Spot Award twice at Glenmark pharmaceuticals Limited.I am seeking a Quality Assurance Specialist position, where can I leverage my skills in Quality Assurance and Quality Control to support your mission of ensuring the highest quality and compliance standards in pharmaceutical manufacturing.
Overview
8
8
years of professional experience
4
4
years of post-secondary education
Work History
Quality Assurance Inspector
Neilmed Pharmaceutical Inc.
Santa Rosa, California
4 2024 - Current
- Review and approve Device History Records, ensuring GMP compliance and high-quality standards.
- Lead equipment validation processes (IQ, OQ, PQ), ensuring operational efficiency and compliance.
- Collaborate with teams to prepare and review Non-Conforming Material Reports, driving improvements.
- Perform in-process and finished product sample verifications, ensuring quality benchmarks are met.
- Develop new quality assurance protocols, improving operational efficiency, and regulatory compliance.
- Conduct meticulous audits of production processes, ensuring strict adherence to GMP guidelines and high-quality standards.
- Streamline documentation processes, enhancing compliance and efficiency across quality assurance operations.
- Implement corrective actions for non-conformances, significantly reducing quality issues, and ensuring regulatory compliance.
- Coordinate cross-functional teams to resolve quality-related issues, fostering culture of continuous improvement.
- Analyze quality control data to identify trends, driving informed decision-making and operational improvements.
- Manage reference standards and impurities, ensuring compliance with USP, EP, BP, and IP catalogs.
- Oversee HPLC column lifecycle, optimizing resource use, and reducing costs.
- Reconcile audit trail data monthly, maintaining accurate and compliant records.
- Review log books and documents per cGMP standards, enhancing operational integrity.
- Calibrate HPLC, pH meters, and IR spectrophotometers, ensuring compliance with cGMP standards.
- Mentor junior staff in quality control procedures, fostering culture of continuous improvement and compliance.
- Implement robust quality control measures, significantly improving product consistency and regulatory compliance.
- Lead cross-functional teams to resolve quality issues, ensuring products meet stringent industry standards.
- Coordinate with R&D and production teams to streamline processes, enhancing operational efficiency and product quality.
- Develop and validate analytical methods, driving accuracy and reliability in quality control testing.
Quality Control Officer
Glenmark Pharmaceutical Limited
Baddi, INDIA
12.2016 - 07.2022
- Manage reference standards and impurities, ensuring compliance with USP, EP, BP, and IP catalogs.
- Approved incoming materials by confirming specifications and taking measurement tests.
- Inspected incoming products for adherence to labeling laws and company quality standards.
- Oversee HPLC column lifecycle, optimizing resource use, and reducing costs.
- Reconcile audit trail data monthly, maintaining accurate and compliant records.
- Review log books and documents per cGMP standards, enhancing operational integrity.
- Calibrate HPLC, pH meters, and IR spectrophotometers, ensuring compliance with cGMP standards.
- Implement robust quality control measures, significantly improving product consistency and regulatory compliance.
- Coordinate with R&D and production teams to streamline processes, enhancing operational efficiency and product quality.
- Develop and validate analytical methods, driving accuracy and reliability in quality control testing.
Education
Bachelor's in Pharmaceutical Science -
Rayat Bahra University
02.2012 - 05.2016
Skills
Quality Control Analysis
Sampling procedures
Teamwork and Collaboration
Safety Compliance
Time management abilities
Problem-solving abilities
Six Sigma Methodologies
Auditing Techniques
Systems Analysis
Technical knowledge
Quality Management Systems
Quality Control Analysis
Accomplishments
- Selected as gold tier member of the president's club in Glenmark Pharmaceutical Limited, India.
- Received spot award two times in Glenmark Pharmaceutical.
Languages
Hindi (Native)
Punjabi (Native)
References
Neilmed Pharmaceuticals
- Lisa Downing
707-525-3784
- Amritpal Singh
707-807-4648
Glenmark Pharmaceuticals
- Mr. Nitesh Kumar
NITI1990K@GMAIL.COM
Timeline
Quality Control Officer
Glenmark Pharmaceutical Limited
12.2016 - 07.2022
Bachelor's in Pharmaceutical Science -
Rayat Bahra University
02.2012 - 05.2016
Quality Assurance Inspector
Neilmed Pharmaceutical Inc.
4 2024 - Current
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