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.
Hi, I’m
Ashish Savaliya
Ahmedabad
Summary
Overview
14
years of professional experience
1
Certification
Work History
Troikaa PharmaceuticalsAhmedabad
Deputy Manager QA
04.2024 - Current
Job overview
- 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.
Emcure Pharmaceuticals
Assistant Manager QA
04.2021 - 04.2024
Job overview
- 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.
Intas Pharmaceutical Ltd.
Senior Executive QA
02.2012 - 04.2021
Job overview
- 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.
Indica Laboratories
Production Chemist
08.2011 - 01.2012
Job overview
- 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
NIMS UniversityJaipur
M.Pharma from Master of Pharmacy
07-2011
University Overview
N R Vekariya College of PharmacyJunagadh
B.Pharma from Pharmacy
06-2009
University Overview
R.P.T.P Science SchoolVallabh Vidyanagar
12th from Higher Secondary School
05-2005
University Overview
K.R.R. Gardi VidyalayaGujarat
10th from Secondary High School
04-2003
University Overview
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
Accomplishments
- Continuous 9+ quality rating (out of 10) in batch release activity at Emcure Pharmaceuticals
- Quality Excellence Award at Intas Pharmaceuticals Ltd
Personal Information
Personal Information
References
References
References available upon request.
Languages
Languages
- English
- Hindi
- Gujarati
- C1
- 5
- C2
- 6
Projects
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
NIMS University
M.Pharma from Master of Pharmacy
N R Vekariya College of Pharmacy
B.Pharma from Pharmacy
R.P.T.P Science School
12th from Higher Secondary School
K.R.R. Gardi Vidyalaya
10th from Secondary High School
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