Quality Assurance Associate
Open To Work
Abhishek Bhatt
Dr. Reddy's Laboratories
Hyderabad
Work Preference
Desired Job Title
Quality Assurance AssociateExecutive- QAQuality Assurance Specialist
Work Type
Full Time
Location Preference
On-SiteRemoteHybrid
Location:
denmarkitalynew yorkswitzerlandaustralia
Open to relocation:
Yes
Quality Assurance Professional with 3+ years of experience driving cGMP compliance, QMS oversight, and in-process QA operations in biopharmaceutical manufacturing. Possesses deep core expertise in Drug Substance operations-including shop floor operations, deviation management, RCA, CAPA execution, Cleaning validation, PPQ and batch release-with transferable skills applicable across different QA functions. Skilled at bridging technical execution with rigorous quality compliance to ensure operational excellence.
3
Languages
3
Years of experience
3
years of post-secondary education
Work History
Quality Assurance Associate
8 Months
Dr. Reddy's Laboratories - Hyderabad | 01.2026 - Current
- Reviewed batch records and performed batch release for executed batch records ensuring on-time disposition and strict TAT compliance.
- Functioned as QA subject matter expert (SME) and single point of contact (SPOC) for downstream processing, conducting investigations and addressing quality challenges.
- Drove end-to-end QA oversight for Drug Substance (API/Biologics) manufacturing, streamlining SAP, LIMS, and MES (PAS-X) digital workflows to optimize batch review cycle.
- Led cross-functional deviation investigations; designed and implemented robust CAPA plans that reduced recurrence of critical quality events
- Evaluated change controls for process modifications and equipment updates, conducting risk-based assessments that enhanced approval turnaround time while ensuring regulatory adherence.
- Successfully supported and participated in EMA and FDA regulatory audits, contributing to compliant and favorable audit outcomes.
Executive- QA
2 Years 4 Months
Enzene Biosciences - Pune | 08.2023 - 12.2025
- Conduct in-process quality checks to ensure compliance with standard operating procedures (SOPs) and quality specifications.
- Managed all shop floor activities, including line clearance, vial issuance, dispensing, logbook verification, drug substance filtration, and storage.
- Review batch records, process validation, cleaning validation protocols and reports, investigation reports related to deviations ensuring all documentation meets regulatory requirements.
- Conducted thorough reviews of all documents related to regulatory submissions to verify completeness, accuracy, and compliance with regulatory requirements, resulting in successful submissions with minimal requests for additional information.
- Assess and document any changes in processes, equipment, or materials, ensuring they are evaluated for potential impact on product quality through change control.
- Controlled documentation and data for the manufacturing department, categorizing, version-controlling, and making all documents accessible to relevant personnel.
Apprenticeship- QA
4 Months
Tirupati Medicare Limited - Himachal Pradesh | 06.2021 - 10.2021
- Acquired practical experience in Good Manufacturing Practices (GMP) and pharmaceutical quality systems to support operational excellence.
- Assisted in reviewing and maintaining QA documentation, including batch records, SOPs, and related quality documents.
- Studied fundamentals of deviation, CAPA, change control, and OOS/OOT processes to enhance understanding of quality assurance.
- Supported QA personnel in maintaining documentation accuracy, ensuring data integrity, and achieving GMP compliance.
Education
M. Pharm - Pharmacology
Sardar Bhagwan Singh University - Dehradun, Uttarakhand
11.2021 - 08.2023
B. Pharm
Uttaranchal University - Dehradun, Uttarakhand
08.2017 - 06.2021
Skills
GMP Compliance
Quality Management System
SOP preparation
Deviation
CAPA
Change control
Data Review
Document management
Accomplishments
- Facilitated end-to-end technology transfer of multiple products from R&D to commercial manufacturing site.
- Directed scale up operations for multiple product batches expanding volume from lower to higher scale at manufacturing sites.
- Served as SME during regulatory audits focusing on drug substance quality assurance and compliance.
Languages
Hindi
C2
Bilingual or Proficient
English
C1
Advanced
Gharwali
C2
Bilingual or Proficient
Interests
Passionate about the world of finance and investing always trying to expand my knowledge and skills
Basketball enthusiast, playing both for fun and to maintain an active lifestyle
Timeline
Quality Assurance Associate
Dr. Reddy's Laboratories
01.2026 - CurrentRead more
Executive- QA
Enzene Biosciences
08.2023 - 12.2025Read more
Sardar Bhagwan Singh University - M. Pharm, Pharmacology
11.2021 - 08.2023Read more
Apprenticeship- QA
Tirupati Medicare Limited
06.2021 - 10.2021Read more
Uttaranchal University - B. Pharm,
08.2017 - 06.2021Read more