Pinky Balani
Thane
Summary
Highly skilled Senior Quality Manager with broad experience in manufacturing and service industries. Strengths include process improvement, quality assurance, compliance management, and team leadership. Proven track record of improving product quality and integrating effective quality control systems into existing operations.
Overview
15
15
years of professional experience
1
1
Certification
Work History
Senior Quality Manager
Advanz Pharma
06.2018 - Current
- Supervised teams of four direct reports and four indirect reports, handling process validations, ITQA compliance, and product quality reviews.
- Compiled and shared team KPI metrics for monthly reviews.
- Approved process validation documents, computerized system validation documents, and PQRs.
- Engaged in QMS tasks, encompassing evaluation of Change Control, Deviation, CAPA, and Quality Risk Management.
- Participated in regulatory inspection processes.
- Led quality assurance for mergers, acquisitions, and new product launches.
- Managed implementation of Veeva Vault System within budget and on time.
- Reviewed and ensured compliance of quality technical agreements to necessary standards.
- Conducted reviews of procedures focusing on validations, ITQA compliance, and PQRs.
- Coordinated product recalls and managed the communication with regulatory authorities and customers.
- Evaluated risks and coordinated communication with multiple regulatory agencies.
Senior Technical Specialist
Advanz Pharma
03.2014 - 05.2018
- Conducted thorough reviews of Master manufacturing documents.
- Reviewed process validation documents in accordance with Annex 15 guidelines.
- Supported regulatory variations with detailed technical justifications for solid orals, liquids, and sterile forms.
- Handled regulatory inquiries during variation review.
- Managed Change Controls, CAPAs, and deviation investigations in a TrackWise system.
- Managed technology transfer projects.
Executive - R&D
Omni Active Health Technologies
01.2014 - 02.2014
- Developed and optimized nutraceutical formulations.
- Compiled detailed reports on product development progress.
Research Associate
Ajanta Pharma
11.2010 - 01.2014
- Developed solid oral dosage forms for regulated regions, including ANDA and Europe.
- Conduct lab-scale trials to develop prototype formulas.
- Conducted detailed searches and evaluations for patents, innovator samples, excipients, and packaging materials. Performed comprehensive preformulation studies to identify suitable manufacturing processes, and conducted trial batches.
- Develop, execute, and assess stability programs adhering to ICH guidelines.
- Developed transfer documents for technology and handled issues across production departments.
- Optimized current products, resulting in higher quality and cost savings.
- Prepared product development reports, master formula records, and stability protocols.
- Conducted scale-up trials, resolved deviations from target effectively.
Education
Master of Pharmacy -
P.Dr.V.V.P.F's College of Pharmacy
Ahmednagar, Pune, India01-2010
B.Pharm -
Government College of Pharmacy
Amravati, India01-2008
12th -
Vidhyabharati College of Science
India01-2004
10th -
Holy Cross Convent School
India01-2002
Skills
- Formulation Development
- Process validation
- Computerized System Validation
- Due Diligence and Integrations
- Project management
- Product Quality Reviews
- Leadership and management
- Quality management
- Regulatory compliance
- KPI reporting
- Cross-functional collaboration
- Budget preparation
- Risk assessment
- Change control
- CAPA management
Certification
- PRINCE2 Foundation and Practitioner in Project Management
- Annex 15: Process validation certified by NSF
- Validation of the sterile process certified by NSF
- ECA-certified Validation Manager
- ISPE-certified GAMP5, Annex 11 / Part 11 Basic Principles
- KSL Certified Management Essentials Training
Awards
- Rewarded for dealing with the issues during the launch of the new product to allow the release of launch batches
- Rewarded for supporting during the submission of a new product
Hobbies and Interests
- Cooking
- Reading
Projects
- M. Pharm project, microwave-assisted synthesis of N-substituted-7-hydroxy-4-methyl-2-oxoquinoline, and their pharmacological evaluation
- Veeva Vault System Implementation, Project Manager for the implementation of the Veeva Vault System for Vault Quality, as well as Vault RIM
- New product integrations, quality lead for the integration of new products in the Advanz Pharma portfolio
Disclaimer
I hereby declare that all above information is in correct with fact or truth up to my knowledge and I bear the responsibilities for the correctness of the above mentioned particulars.
Languages
- Hindi
- English
- Marathi
Personal Information
- Father's Name: Hiranand Balani
- Date of Birth: 06/25/86
- Gender: Female
- Marital Status: Married
Accomplishments
- Project management of Veeva Vault implementation within budget and specified timelines
- Led the successful HPRA inspection
Timeline
Senior Quality Manager
Advanz Pharma
06.2018 - Current
Senior Technical Specialist
Advanz Pharma
03.2014 - 05.2018
Executive - R&D
Omni Active Health Technologies
01.2014 - 02.2014
Research Associate
Ajanta Pharma
11.2010 - 01.2014
Master of Pharmacy -
P.Dr.V.V.P.F's College of Pharmacy
B.Pharm -
Government College of Pharmacy
12th -
Vidhyabharati College of Science
10th -
Holy Cross Convent School