Summary
Overview
Work History
Education
Skills
Certification
Accomplishments
Personal Information
References
Languages
Projects
Languages
Timeline
Generic
Ashish Savaliya

Ashish Savaliya

Ahmedabad

Summary

Dedicated quality assurance professional with extensive experience in maintaining Quality Management Systems and ensuring adherence to cGMP standards. Proficient in Quality Risk Management and In-Process Quality Assurance, contributing to continuous improvement and regulatory compliance.

Overview

14
14
years of professional experience
1
1
Certification

Work History

Deputy Manager QA

Troikaa Pharmaceuticals
Ahmedabad
04.2024 - Current
  • Oversee and maintain the Quality Management System to adhere to cGMP and regulatory requirements.
  • Align all procedures, protocols, and documentation with internal and external regulatory guidelines.
  • Monitor QMS performance using quality metrics and Key Performance Indicators (KPIs).
  • Drive initiatives to enhance QMS processes and systems, ensuring continuous regulatory compliance.
  • Assist in drafting and updating Standard Operating Procedures (SOPs), GAP Assessment.
  • Conduct routine in-process checks during manufacturing and filling stages to ensure adherence to product specifications and GMP standards.
  • Supervise aseptic processes, and ensure compliance with sterile practices.
  • Monitor critical process parameters (CPP) and critical quality attributes (CQA) during production.
  • Review batch manufacturing records (BMR) and batch packaging records (BPR) for completeness and accuracy.
  • Ensure timely closure of observations and non-conformances related to IPQA activities.
  • Review the validation protocols and reports (process validation, cleaning validation, equipment qualification) to ensure alignment with regulatory and company standards.
  • Collaborate with cross-functional teams (Production, Engineering, and Quality Assurance) to address validation-related requirements effectively.

Assistant Manager QA

Emcure Pharmaceuticals
04.2021 - 04.2024
  • Ensured compliance with regulatory guidelines, pharmacopeial standards, and company-specific procedures to uphold regulatory requirements.
  • Collaborated with cross-functional teams to verify manufacturing, packaging, labeling, and distribution processes align with regulatory standards.
  • Maintained an updated understanding of current Good Manufacturing Practices (cGMP) and relevant quality standards.
  • Reviewed and assessed batch manufacturing records, analytical data, and quality control documentation to validate adherence to established specifications and procedures.
  • Ensured completeness and accuracy of documentation related to batch manufacturing, packaging, and testing, in accordance with regulatory guidelines.
  • Responsible for batch release activity, including product approval or rejection, based on comprehensive evaluation of quality data and compliance with defined criteria.
  • Conducted risk assessments and contributed to investigations of deviations, non-conformances, and customer complaints, leading to effective corrective and preventive actions.
  • Maintained accurate and complete records of batch release activities, quality assessments, and regulatory compliance measures.

Senior Executive QA

Intas Pharmaceutical Ltd.
02.2012 - 04.2021
  • Conducted IPQA and QMS related activities to ensure compliance with quality standards.
  • Executed line clearance procedures to maintain aseptic conditions during manufacturing processes.
  • Reviewed EBMR and EBPR to identify and address any deviations or non-conformances.
  • Actively participated in Periodic Validation processes to ensure continuous compliance with regulatory requirements.
  • Monitored in-process activities thoroughly to identify and resolve any quality issues.
  • Oversaw the monitoring of non-viable particle count to maintain sterile manufacturing environments.
  • Supervised aseptic area filling and sealing activities to ensure product integrity and quality.
  • Implemented standard operating procedures (SOP) to maintain consistency in quality protocols.
  • Conducted Acceptable Quality Level (AQL) inspections to uphold product quality standards.
  • Utilized process data to drive improvements.

Production Chemist

Indica Laboratories
08.2011 - 01.2012
  • Conducted sampling to ensure material quality and compliance.
  • Performed dissolution, friability, hardness, and weight variation tests accurately.
  • Executed comprehensive testing protocols to maintain production standards.

Education

M.Pharma - Master of Pharmacy

NIMS University
Jaipur
07-2011

B.Pharma - Pharmacy

N R Vekariya College of Pharmacy
Junagadh
06-2009

12th - Higher Secondary School

R.P.T.P Science School
Vallabh Vidyanagar
05-2005

10th - Secondary High School

K.R.R. Gardi Vidyalaya
Gujarat
04-2003

Skills

  • Quality management system (QMS)
  • Document review
  • Regulatory audit handling
  • Self inspection
  • Change control assessment
  • Quality risk management
  • In-process quality assurance (IPQA)
  • Process validation
  • Cleaning validation
  • Batch release and QP coordinator
  • Deviation management
  • CPVR
  • Media fill
  • Investigation
  • Corrective and preventive actions (CAPA)
  • Sterile processing and compliance

Certification

Indian Pharmacy Congress

Accomplishments

  • Continuous 9+ quality rating (out of 10) in batch release activity at Emcure Pharmaceuticals
  • Quality Excellence Award at Intas Pharmaceuticals Ltd

Personal Information

References

References available upon request.

Languages

  • English
  • Hindi
  • Gujarati
  • C1
  • 5
  • C2
  • 6

Projects

Formulation, Development & Evaluation of Salbutamol Sulphate Oral Disintegrating Tablet, 151 Days, To formulate & evaluate slabutamol sulphate oral disintegrating tablets.

Languages

guy
First Language
English
Advanced (C1)
C1
his
Proficient (C2)
C2

Timeline

Deputy Manager QA

Troikaa Pharmaceuticals
04.2024 - Current

Assistant Manager QA

Emcure Pharmaceuticals
04.2021 - 04.2024

Senior Executive QA

Intas Pharmaceutical Ltd.
02.2012 - 04.2021

Production Chemist

Indica Laboratories
08.2011 - 01.2012

M.Pharma - Master of Pharmacy

NIMS University

B.Pharma - Pharmacy

N R Vekariya College of Pharmacy

12th - Higher Secondary School

R.P.T.P Science School

10th - Secondary High School

K.R.R. Gardi Vidyalaya

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Ashish Savaliya