Operating Systems & Office Tools: Windows XP, 7, 8 & 10; MS Office Suite (Excel, Word, PowerPoint); SmartDraw
Open To Work
Anjali Sharma
Manager Quality
Pehowa
Summary
Results-driven Quality Assurance professional with extensive expertise in pharmaceutical manufacturing, regulatory compliance, and global quality systems. Proven track record in managing audits, CAPA processes, and risk assessments while fostering collaboration among cross-functional teams worldwide. Proficient in ensuring adherence to US FDA, EMA, and GMP standards while championing continuous improvement initiatives that enhance product quality and operational efficiency. Committed to delivering strategic oversight and proactive problem-solving to drive excellence in quality assurance practices.
Overview
10
10
years of professional experience
1
1
Language
Work History
Quality Manager
Teva Pharmaceuticals External Manufacturing and Supply Operations (ExM) through Strotus Corpsol
10.2025 - Current
- Participating global quality oversight for commercial products manufactured, tested, and released at Contract Manufacturing Organizations (CMOs), ensuring compliance with corporate and regulatory standards.
- Managing execution of ExM quality projects, driving adherence to Teva’s global quality framework, GMP requirements, and international regulatory guidelines (FDA, EMA, etc.).
- Partnered with external manufacturing sites to establish and strengthen robust quality systems aligned with global and internal standards.
- Conducting gap analyses and risk assessments, implementing effective CAPA strategies to proactively mitigate potential quality issues.
- Serving as the key liaison between global and regional quality teams, ensuring seamless alignment and execution of ongoing projects across geographies.
- Providing strategic support and development initiatives to external manufacturing quality teams, fostering consistency in best practices.
- Standardizing procedures by analyzing corporate policies against local practices, designing and implementing harmonized processes to meet global regulatory requirements.
- Planning and executing remediation projects, ensuring smooth transitions, timely completion, and compliance with regulatory expectations.
Assistant Professor
R.S.M Collage of Pharmacy
01.2025 - 09.2025
- Deliver lectures and practical sessions in pharmacy subjects (Pharmaceutics and Pharmaceutical Chemistry etc.) as per PCI curriculum.
- Prepare lesson plans, study materials, and maintain academic records in compliance with institutional and regulatory requirements.
- Guide and mentor students in academics, projects, and dissertations.
- Conduct and evaluate examinations, assignments, and internal assessments.
- Ensure laboratory compliance, including SOP adherence, equipment maintenance, and safety practices.
- Assist in curriculum development, accreditation processes (PCI/NAAC), and academic audits.
- Engage in administrative responsibilities such as timetable coordination, committee work, and student activities.
Officer– Quality Assurance
Glenmark Pharmaceutical Limited
02.2021 - 03.2023
- Managed the issuance and retrieval of analytical test data sheets and laboratory log books to ensure traceability and compliance.
- Initiated, reviewed, and compiled Change Controls and CAPA, driving continuous improvement, and regulatory adherence.
- Investigated and resolved market complaints for semisolid external preparations, performing root cause analysis, and implementing CAPA in line with GMP standards.
- Coordinated cross-functional teams (QA, QC, Production) to ensure timely documentation, trending, and closure of complaints.
- Conducted comprehensive reviews of analytical data, batch production records, cleaning records, and certificates of analysis to maintain product quality.
- Led the preparation and review of Quality Risk Assessments using FMEA, Fishbone, and 5 WHYs methodologies across multiple domains.
- Prepared and reviewed Annual Product Quality Reviews (APQR) and trend analyses to monitor product performance.
- Developed and analyzed Continued Process Verification (CPV) reports using Minitab software to ensure process consistency.
- Conducted risk assessments for nitrosamines in drug products, ensuring regulatory compliance, and patient safety.
- Designed and delivered training programs for new employees, scheduling and tracking training to build workforce competency.
- Actively participated in regulatory audits, ensuring facility readiness, and successful compliance outcomes.
Quality Specialist– Quality Assurance
Teva API India Private Limited
05.2019 - 09.2020
- Oversaw the issuance and retrieval of analytical test data sheets, Batch Production Records (BPR), Batch Manufacturing Records (BMR), and Batch Cleaning Records (BCR).
- Reviewed and compiled change controls to ensure regulatory compliance and process integrity.
- Led investigations of laboratory incidents, out-of-specification (OOS) results, and deviations, performing root cause analysis and implementing corrective and preventive actions (CAPA) in alignment with Good Manufacturing Practice (GMP) standards.
- Conducted detailed reviews of analytical data, stability study results, product release documentation, and certificates of analysis.
- Prepared and reviewed Quality Risk Assessments using FMEA, Fishbone, and 5 WHYs methodologies across diverse operational areas.
- Developed and analyzed Periodic Product Quality Reviews (PQRs) and trend analyses to monitor product consistency.
- Reviewed and approved BPRs and BCRs to ensure accuracy and compliance with SOPs.
- Evaluated process parameter reports, time limitations, and stoppage point data for operational efficiency.
- Conducted internal quality audits and site-wide compliance audits to maintain regulatory readiness.
- Performed quality risk assessments for nitrosamines in drug substances to safeguard patient safety.
- Executed ongoing supplier quality monitoring through periodic assessments.
- Reviewed compendia standards, in-house specifications, methods of analysis, and method validation reports to ensure scientific and regulatory robustness.
Officer– Quality Assurance
Coral Drugs Private Limited
09.2016 - 05.2019
- Prepared and reviewed Standard Operating Procedures (SOPs) to ensure clarity, compliance, and operational efficiency.
- Oversaw the issuance and retrieval of analytical test data sheets, Batch Production Records (BPR), Batch Manufacturing Records (BMR), and Batch Cleaning Records (BCR).
- Reviewed and compiled Change Controls to maintain regulatory compliance and process integrity.
- Investigated laboratory incidents, OOS results, and deviations, performing root cause analysis, and implementing CAPA in line with GMP guidelines.
- Handled market complaints for APIs, conducting investigations, root cause analysis, and CAPA implementation in compliance with regulatory standards.
- Conducted reviews of analytical data, product release documentation, and certificates of analysis to ensure product quality.
- Reviewed stability data to monitor product performance and shelf life.
- Applied Quality Risk Assessment methodologies (FMEA, Fishbone, 5 WHYs) to identify and mitigate risks across processes.
- Executed ongoing supplier quality monitoring through periodic assessments to ensure compliance and reliability.
- Reviewed compendial standards, in-house specifications, and methods of analysis for scientific and regulatory robustness.
- Prepared and reviewed Periodic Product Quality Reviews (PQRs) and trend analyses to evaluate product consistency.
- Reviewed instrument audit trails (HPLC, GC, IR, UV, etc.), ensuring data backup and integrity in compliance with 21 CFR Part 11, and applicable guidelines.
Education
B.Pharma -
B. P.S. Mahila Vishwavidyalaya
01-2016
10+2th - undefined
Dr. M.K.K. Arya Model School
01-2012
10th - undefined
Hari Bhoomi Public School
01-2010
Skills
Leadership & Team Management – guiding cross-functional teams to achieve quality and compliance goals
Communication Skills – clear, structured communication with regulatory bodies, auditors, and internal teams
Problem-Solving & Critical Thinking – analyzing complex issues and implementing effective solutions
Time Management & Prioritization – meeting strict deadlines in documentation, audits, and regulatory submissions
Collaboration & Stakeholder Engagement – working effectively with QA, QC, Production, and external partners
Adaptability & Flexibility – adjusting to evolving regulatory requirements and organizational priorities
Decision-Making – making informed, timely decisions in high-stakes quality and compliance scenarios
Attention to Detail – ensuring accuracy in documentation, reporting, and compliance processes
Training & Mentorship – developing team capabilities through structured training and coaching
Project Management – planning, executing, and closing projects within timelines and compliance frameworks
EXTRACURRICULAR ACTIVITIES
Participated in “1st Women Parliament at B.P.S University, Khanpur Kalan”. Active participant of “Science Association ” at School.
Additional Information
- Successfully faced and supported multiple regulatory and compliance audits, ensuring full adherence to global standards and smooth closure of observations.
- Direct involvement in audits conducted by major regulatory authorities, including:
USFDA (United States Food & Drug Administration)
EMA (European Medicines Agency)
MHRA (Medicines and Healthcare products Regulatory Agency, UK)
WHO (World Health Organization)
TGA (Therapeutic Goods Administration, Australia)
ANVISA (Brazilian Health Regulatory Agency)
Local Indian authorities (CDSCO, State FDA) - Actively participated in internal audits, corporate audits, and client audits, ensuring site readiness and compliance with GMP, data integrity, and quality standards.
- Collaborated with cross-functional teams during audit preparation and execution, contributing to successful outcomes and zero critical observations.
Software
Enterprise & Quality Systems: ERP, TrackWise, Veeva, SAP, Glorya
Statistical & Analytical Tools: Minitab (versions 16 & 20), LIMS
Interests
Enjoy to play Basketball and Badminton,, Listening to Music, Spiritual Books
INTERNSHIP
- Organization: Laborate Pharmaceuticals Private Limited
- Role &Responsibility: I become familiar with
- Production and Packing of tablets and capsules.
- Quality Control
- Quality Assurance
AWARDS
Winner in Quiz Competition in pharmacy week., Winner in Model making and Presentation on “Nanotechnology: Diagnostic and Therapeutic Applications., Winner in Speech Competition held at Campus.
Work Preference
Job Search Status
Open to workWork Type
Full TimePart TimeContract WorkLocation Preference
RemoteHybridOn-SiteSalary Range
₹45000/yr - ₹200000/yrTimeline
Quality Manager
Teva Pharmaceuticals External Manufacturing and Supply Operations (ExM) through Strotus Corpsol
10.2025 - Current
Assistant Professor
R.S.M Collage of Pharmacy
01.2025 - 09.2025
Officer– Quality Assurance
Glenmark Pharmaceutical Limited
02.2021 - 03.2023
Quality Specialist– Quality Assurance
Teva API India Private Limited
05.2019 - 09.2020
Officer– Quality Assurance
Coral Drugs Private Limited
09.2016 - 05.2019
10+2th - undefined
Dr. M.K.K. Arya Model School
10th - undefined
Hari Bhoomi Public School
B.Pharma -
B. P.S. Mahila Vishwavidyalaya