Kavitha Avula
Ongole
Summary
Accomplished QMS Lead with extensive experience at Pfizer Healthcare, excelling in regulatory compliance and tech transfer. Proven track record in strategic alignment and relationship building, recognized with 15 PGS Mission awards. Proficient in SAP DMS and adept at leading cross-functional teams to drive continuous improvement and ensure site quality compliance.
Overview
15
15
years of professional experience
1
1
Certification
Work History
QMS Lead
Extrovis Private Limited
Hyderabad
- Current
- Successfully handling of Audits (Regulatory audits, Customers audits and External Audits & Internal audits).
- Playing a key role in the design and implementation of Quality Management System and Document Management System for the organization alongside ensuring that the standards meet the current regulatory requirements.
- Review and Approval of Investigations, OOS, OOT’s & Market Complaints.
- Involving in Commercial Dispatch and Decision maker on release of FP and returned goods.
- Involving in continuous improvement activities w.r.t GDP, GLP, cGMP & training management.
- Handling of Sampling management system, Vendor management.
- Involving in third party manufacturing activities along with customer /market complaints.
- Coordinator and ideas given to Ample logic software updates in Pharma R&D and Plant locations.
- Implemented a system to help organize the communication between my coworkers to enhance our productivity as a team.
Tech Transfer Team Activities QMS & Investigations
Pfizer Healthcare Private Limited
01.2011 - 06.2023
- Received 15 PGS Mission awards in Pfizer Health care Pvt. Ltd.
- Approval of all regulatory documents like Specifications, STP’s, Validation reports, RES/EI/Nitrosamine assessment/ Stability protocols etc.
- Change control management end to end of process workflow: gQTS process flow for Preparation of change records within site and extending to global sites and ensure within the timelines.
- Alternate vendor qualifications for raw materials, Packaging materials & Preparation of documents through PDOC’S & having well versed knowledge on PDOC’S process flow.
- Gap assessments review and preparation of products, Documentation as per WHO GMP, MHRA.
- Review and approval of SOPs, specifications, STPs, APQR, MFR, BMR, BPR, Equipment, HVAC, Process validation, cleaning validation, water system qualification protocols review and reports.
- Understanding AND Knowledge on ICH Q6 and Q3A &B etc, ICH Q3D US-FDA& PIC Guidelines for specification, Impurities/ residual solvents/EI and clinical studies etc.
- Support all the requirements of Regulatory submissions.
- Review and approval of Change controls, Deviations, CAPAs, OOS and OOT.
- Review and approval of Art works.
- Good knowledge on overall tech transfer workflow from end to end process of products.
- Review of MOC studies, CPP’s, CQA’s protocols & reports.
- Evaluation/Assessments and scientific disposition of changes with impact assessment from quality and regulatory perspective.
- Review of Supplier DMF’s & accessing gaps.
- Review of Compendia impact assessments USP, EP compendia changes and implementation of Compendia changes on impacted documents.
- Regulatory Batch records preparation, revisions for molecules to support regulatory filing.
- Well worse knowledge on regulatory filing categories, CBE-0, CBE-30, PAR& Annual reportable with respect to changes implementation etc.
Education
M. Pharmacy - Pharmacology
VELS UNIVERSITY
Chennai01.2010
B.Pharmacy -
Sri Lakshmi Narasimha College of Pharmacy
Chittoor01.2008
Skills
- MS-Word
- HTML
- SAP DMS
- MS-Excel
- DOS windows 9X 2000
- MS Office
- SAP MDM
- GQTS Track wise systems
- Ample logic
- PDOC
- P-LOG systems
- Document generation
- Independent work
- Change agile
- Strategic alignment
- Relationship building
- Project deliverables
- End-end process knowledge
- Tech transfer molecules
- Interpretation skills
- Self-learning skills
- Verbal communication
- Written communication
- Site Quality compliance
- Leadership in Injectable formulations
- Leadership in Oral formulations
Certification
- ISO 9001:2015 Lead Auditor, INTERNATIONAL MANAGEMENT CONSULTANCY, MM/DD/YY
- Yellow Belt (M1-6 Sigma tools), MM/DD/YY
Accomplishments
- Received 15 PGS Mission awards in Pfizer Health Care Pvt. Ltd.
- Closure of Manufacturing Investigations, CAPA’s within timelines without impacting Quality.
Languages
- English
- Telugu
- Tamil
- Hindi
Disclaimer
I declare that the above information furnished is true to the best of my knowledge and belief.
Projects Executed
- Nebivolol HCl Oral solution
- Allopurinol Oral Suspension
- Cetrorelix Injection
- Liraglutide Injection
- Cefepime for Injection
- Temozolomide
- Methotrexate
- Ifosfamide injection
- Calcium gluconate in Sodium chloride injection
- Ondansetron Injection, USP
- Propofol Injectable Emulsion, USP
- Furosemide Injection, USP
- Potassium Chloride for Injection USP
- Metoclopramide Injection, USP
- Sodium Chloride Injection, Bact. Sodium Chloride Injection
- Bupivacaine and Marcaine Injection
- Lidocaine Hydrochloride Injection
- Heparin Sodium Injection, USP
- Aminocaproic acid, US
- Carbocaine injection, USP
- Verapamil injection, USP
- Potassium Acetate injection, USP
- Sodium Acetate injection, USP
- SWBI & BWFI, USP
- Midazolam Injection, USP
- Precedex
- Ketorolac Tromethamine USP
Personal Information
- Father's Name: A. Malyadri
- Spouse's Name: N. Srinadh
- Gender: Female
- Nationality: Indian
- Marital Status: Married
- Religion: Hindu
Timeline
Tech Transfer Team Activities QMS & Investigations
Pfizer Healthcare Private Limited
01.2011 - 06.2023
QMS Lead
Extrovis Private Limited
- Current
M. Pharmacy - Pharmacology
VELS UNIVERSITY
B.Pharmacy -
Sri Lakshmi Narasimha College of Pharmacy
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