HARIKA PARUCHURI
QUALITY ASSURANCE SPECIALIST
Dayton,OH
Summary
A passionate Quality Assurance specialist with 3.5 years of experience successfully managed various aspects of QA, including cGMP manufacturing projects, change controls, deviations, CAPA, investigations, validation activities, and documentation review. Expertised in risk and issue management, auditing, and mentoring teams to thoroughly assess product quality and manufacturing processes.
Overview
3
3
years of professional experience
7
7
years of post-secondary education
Work History
Quality Assurance Executive
Indu Drugs Pvt. Ltd
03.2020 - 09.2021
- Managed change control process, deviations, OOS, and OOTs
- Oversaw change controls, CAPAs, deviations, investigations, and validation activities
- Resolved issues and tracked change controls quickly and efficiently with a finely tuned database
- Reviewed and approved Quality Management System (QMS) documents related to multiple projects, including SOPs, Material and Product Specifications, Master Production Records, Batch Manufacturing Recor, Logbooks Validation Protocols, and Reports
- Assisted in the preparation and submission of regulatory documentation, such as drug master files and regulatory submissions
- Participated in internal and external audits of the company's processes and facilities
- Conducted quality investigations and root cause analyses
- Ensured that products were in accordance with existing requirements and parameters through proper audit, examination, and testing activities
Quality Assurance Specialist
Indu Drugs Pvt. Ltd
05.2019 - 02.2020
- Conducted cGMP, GDP, and GLP training
- Verified the documentation of cross-functional teams (CFT)
- Initiated, reviewed, and updated the Quality Manual and Standard Operating Procedures, as well as implemented a Change Control system
- Performed detailed document reviews to perform product release activities, including batch manufacturing records and logbook reviews
- Designed and established Quality Management Systems documents such as Standard Operating Procedures according to Quality policies and procedures, in accordance with local regulations
- Accountable for keeping track of quality systems documents and requests per the rules of local regulations and internal processes.
- Monitored product standards and quality-control programs.
- Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.
Quality Assurance Trainee
Indu Drugs Pvt. Ltd
05.2018 - 04.2019
- Drafted standard operating procedures (SOP) & standard testing procedures (STP) for manufacturing, quality assurance, and quality control departments
- Handled Batch manufacturing records (BMR), batch packing records (BPR), Control copies, and Spec issuance to cross-functional teams
- Documented master copies
- Retrieved executed and revised documents
- Managed archival process by ensuring compliance with regulatory requirements.
Education
Master of Science - Pharmacology And Toxicology
Wright State University
Dayton 01.2022 - 04.2023
Master of Science - Pharmaceutics
Acharya Nagarjuna University
India 10.2018 - 10.2020
Bachelor of Science - Pharmaceutical sciences
Acharya Nagarjuna University
India 08.2014 - 04.2018
Skills
cGMPundefined
Timeline
Master of Science - Pharmacology And Toxicology
Wright State University
01.2022 - 04.2023
Quality Assurance Executive
Indu Drugs Pvt. Ltd
03.2020 - 09.2021
Quality Assurance Specialist
Indu Drugs Pvt. Ltd
05.2019 - 02.2020
Master of Science - Pharmaceutics
Acharya Nagarjuna University
10.2018 - 10.2020
Quality Assurance Trainee
Indu Drugs Pvt. Ltd
05.2018 - 04.2019
Bachelor of Science - Pharmaceutical sciences
Acharya Nagarjuna University
08.2014 - 04.2018
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