404 Quality Assurance Specialists jobs in Mumbai
Quality Assurance Manager
Posted 4 days ago
Job Viewed
Job Description
AMN Life is a leading manufacturer and exporter of a wide range of formulations in various therapeutic segments including antibiotics, gastro, anti-inflammatories, cardiology, nephrology, CNS, and oncology. With facilities approved by EU, Health Canada, Brazil - Anvisa, and Philippines situated in Bhilad (Gujarat) and Kala Amb (Himachal Pradesh), AMN Life is equipped to handle large scale production and tech transfer projects. Headquartered in Bandra Kurla Complex, Mumbai, with offices in Singapore, UK, Australia, and Philippines, AMN Life excels in providing quality medicines at affordable prices globally. We are recognized for our strong global presence, innovative R&D, and impeccable on-time delivery record over the past 20 years.
Location: Kala Amb ( Himachal Pradesh)
Department: Quality Assurance
Reports To: Head – CQA
The Quality Manager will lead and oversee all Quality Assurance (QA) and Quality Control (QC) activities at the formulation plant, ensuring compliance with EU GMP, USFDA, and other global regulatory requirements . The role will focus on generic formulations and β-lactam facilities , ensuring highest product quality, regulatory compliance, and continuous improvement.
- Ensure compliance with EU-GMP, WHO-GMP, USFDA, MHRA, TGA, CDSCO, and other international regulatory standards .
- Review, approve and maintain SOPs, Batch Manufacturing Records (BMRs), Batch Packaging Records (BPRs) , and master documents.
- Oversee deviations, change controls, CAPA, OOS/OOT investigations, and ensure timely closure.
- Lead internal audits, vendor audits, and regulatory inspections ; ensure readiness at all times.
- Manage QMS (Quality Management System) and ensure effectiveness across the site.
- Ensure compliance in cleanroom, microbiological controls, cross-contamination controls specific to β-lactam plant operations .
- Oversee qualification & validation activities – process validation, cleaning validation, equipment qualification, analytical method validation.
- Drive continuous quality improvement initiatives and implement best practices.
- Supervise QC operations including raw materials, in-process, finished product, microbiology, and stability studies .
- Ensure laboratory compliance with GLP and regulatory guidelines.
- Oversee method transfers, verification, and troubleshooting of analytical techniques.
- Approve COAs and analytical reports.
- Ensure plant operations meet EU dossier requirements and customer specifications for generics.
- Prepare and review regulatory submissions, technical files, and CMC documentation .
- Act as primary contact during regulatory audits/inspections and customer audits.
- Lead and develop QA/QC teams with strong focus on training and skill enhancement.
- Ensure effective cross-functional collaboration between Production, Engineering, R&D, Regulatory, and Supply Chain .
- Promote a strong quality culture across the site.
- In-depth knowledge of EU-GMP, ICH guidelines, GLP, WHO GMP, USFDA regulations .
- Expertise in formulations (OSD, injectables, suspensions, etc.) and β-lactam manufacturing processes .
- Strong understanding of sterility assurance, microbiology, and containment strategies for β-lactam facilities .
- Proficient in QMS tools (TrackWise, Veeva, or equivalent).
- Strong leadership, decision-making, and problem-solving skills.
- Excellent communication for handling regulatory agencies and global clients .
- Master’s in Pharmacy / Pharmaceutical Sciences / Chemistry (M.Pharm / M.Sc).
- Minimum 10–15 years of experience in pharmaceutical QA, with at least 7+ years in a managerial role .
- Hands-on experience in formulations, generics, and β-lactam facilities .
- Proven track record of facing EU/MHRA/USFDA inspections .
Salary Range-Not disclosed
Please feel free to connect @ and share your CV at /
Quality Assurance Analyst
Posted 4 days ago
Job Viewed
Job Description
QualityKiosk Technologies is one of the world's largest independent Quality Engineering (QE) providers and digital transformation enablers, helping companies build and manage applications for optimal performance and user experience. Founded in 2000, the company specializes in providing quality engineering, QA automation, performance assurance, intelligent automation (IA) and robotic process automation (RPA), customer experience management, site reliability engineering (SRE), digital testing as a service (DTaaS), cloud, and data analytics solutions and services. With operations spread across 25+ countries and a workforce of more than 4000 employees, the organization enables some of the leading banking, e-commerce, automotive, telecom, insurance, OTT, entertainment, pharmaceuticals, and BFSI brands to achieve their business transformation goals. QualityKiosk Technologies has been featured in renowned global advisory firms' reports, including Forrester, Gartner, The Everest Group, and Hurun Report, for its innovative, IP-led quality assurance solutions and the positive impact it has created for its clients in the fast-changing digital landscape. QualityKiosk, which offers automated quality assurance solutions for clients across geographies and verticals, counts 50 of the Indian Fortune 100 companies and 18 of the global Fortune 500 companies as its key clients. The company is banking on its speed of execution and technology advancement as key factors to drive a 5X growth in the next five years, both in revenues and number of employees.
About the Role
Candidate should have knowledge on CASA and TD, should have knowledge on API Testing and should know how to use Postman.
Required Skills
- Knowledge on CASA, TD, API Testing, and Postman.
- Knowledge on Account Opening, Modification, and Closure.
Responsibilities
- Should have knowledge on Account Opening, Modification and Closure.
- Should have knowledge on Opening of Accounts through Channels.
- Design Test Cases/ Scenarios as per requirements.
- Execute the test plan.
- Record defects in Defect Management Tool.
- Update Project Progress.
- Retesting of defects fixed.
- Daily reporting to Onsite / Offshore Test Manager.
Quality Assurance Analyst
Posted today
Job Viewed
Job Description
About the Role
Candidate should have knowledge on CASA and TD, should have knowledge on API Testing and should know how to use Postman.
Required Skills
Knowledge on CASA, TD, API Testing, and Postman.
Knowledge on Account Opening, Modification, and Closure.
Responsibilities
Should have knowledge on Account Opening, Modification and Closure.
Should have knowledge on Opening of Accounts through Channels.
Design Test Cases/ Scenarios as per requirements.
Execute the test plan.
Record defects in Defect Management Tool.
Update Project Progress.
Retesting of defects fixed.
Daily reporting to Onsite / Offshore Test Manager.
Quality Assurance Manager
Posted today
Job Viewed
Job Description
AMN Life is a leading manufacturer and exporter of a wide range of formulations in various therapeutic segments including antibiotics, gastro, anti-inflammatories, cardiology, nephrology, CNS, and oncology. With facilities approved by EU, Health Canada, Brazil - Anvisa, and Philippines situated in Bhilad (Gujarat) and Kala Amb (Himachal Pradesh), AMN Life is equipped to handle large scale production and tech transfer projects. Headquartered in Bandra Kurla Complex, Mumbai, with offices in Singapore, UK, Australia, and Philippines, AMN Life excels in providing quality medicines at affordable prices globally. We are recognized for our strong global presence, innovative R&D, and impeccable on-time delivery record over the past 20 years.
Location: Kala Amb ( Himachal Pradesh)
Department: Quality Assurance
Reports To: Head – CQA
Position Summary
The Quality Manager will lead and oversee all Quality Assurance (QA) and Quality Control (QC) activities at the formulation plant, ensuring compliance with EU GMP, USFDA, and other global regulatory requirements. The role will focus on generic formulations and β-lactam facilities, ensuring highest product quality, regulatory compliance, and continuous improvement.
Key ResponsibilitiesQuality Assurance (QA)
- Ensure compliance with EU-GMP, WHO-GMP, USFDA, MHRA, TGA, CDSCO, and other international regulatory standards.
- Review, approve and maintain SOPs, Batch Manufacturing Records (BMRs), Batch Packaging Records (BPRs), and master documents.
- Oversee deviations, change controls, CAPA, OOS/OOT investigations, and ensure timely closure.
- Lead internal audits, vendor audits, and regulatory inspections; ensure readiness at all times.
- Manage QMS (Quality Management System) and ensure effectiveness across the site.
- Ensure compliance in cleanroom, microbiological controls, cross-contamination controls specific to β-lactam plant operations.
- Oversee qualification & validation activities – process validation, cleaning validation, equipment qualification, analytical method validation.
- Drive continuous quality improvement initiatives and implement best practices.
Quality Control (QC)
- Supervise QC operations including raw materials, in-process, finished product, microbiology, and stability studies.
- Ensure laboratory compliance with GLP and regulatory guidelines.
- Oversee method transfers, verification, and troubleshooting of analytical techniques.
- Approve COAs and analytical reports.
Regulatory & Compliance
- Ensure plant operations meet EU dossier requirements and customer specifications for generics.
- Prepare and review regulatory submissions, technical files, and CMC documentation.
- Act as primary contact during regulatory audits/inspections and customer audits.
Leadership & Team Management
- Lead and develop QA/QC teams with strong focus on training and skill enhancement.
- Ensure effective cross-functional collaboration between Production, Engineering, R&D, Regulatory, and Supply Chain.
- Promote a strong quality culture across the site.
Key Skills & Competencies
- In-depth knowledge of EU-GMP, ICH guidelines, GLP, WHO GMP, USFDA regulations.
- Expertise in formulations (OSD, injectables, suspensions, etc.) and β-lactam manufacturing processes.
- Strong understanding of sterility assurance, microbiology, and containment strategies for β-lactam facilities.
- Proficient in QMS tools (TrackWise, Veeva, or equivalent).
- Strong leadership, decision-making, and problem-solving skills.
- Excellent communication for handling regulatory agencies and global clients.
Qualifications & Experience
- Master’s in Pharmacy / Pharmaceutical Sciences / Chemistry (M.Pharm / M.Sc).
- Minimum 10–15 years of experience in pharmaceutical QA, with at least 7+ years in a managerial role.
- Hands-on experience in formulations, generics, and β-lactam facilities.
- Proven track record of facing EU/MHRA/USFDA inspections.
Salary Range-Not disclosed
Please feel free to connect @ and share your CV at /
Quality Assurance Manager
Posted 3 days ago
Job Viewed
Job Description
Location: Kala Amb ( Himachal Pradesh)
Department: Quality Assurance
Reports To: Head – CQA
Position Summary The Quality Manager will lead and oversee all Quality Assurance (QA) and Quality Control (QC) activities at the formulation plant, ensuring compliance with EU GMP, USFDA, and other global regulatory requirements . The role will focus on generic formulations and β-lactam facilities , ensuring highest product quality, regulatory compliance, and continuous improvement.
Key Responsibilities Quality Assurance (QA) Ensure compliance with EU-GMP, WHO-GMP, USFDA, MHRA, TGA, CDSCO, and other international regulatory standards .
Review, approve and maintain SOPs, Batch Manufacturing Records (BMRs), Batch Packaging Records (BPRs) , and master documents.
Oversee deviations, change controls, CAPA, OOS/OOT investigations, and ensure timely closure.
Lead internal audits, vendor audits, and regulatory inspections ; ensure readiness at all times.
Manage QMS (Quality Management System) and ensure effectiveness across the site.
Ensure compliance in cleanroom, microbiological controls, cross-contamination controls specific to β-lactam plant operations .
Oversee qualification & validation activities – process validation, cleaning validation, equipment qualification, analytical method validation.
Drive continuous quality improvement initiatives and implement best practices.
Quality Control (QC) Supervise QC operations including raw materials, in-process, finished product, microbiology, and stability studies .
Ensure laboratory compliance with GLP and regulatory guidelines.
Oversee method transfers, verification, and troubleshooting of analytical techniques.
Approve COAs and analytical reports.
Regulatory & Compliance Ensure plant operations meet EU dossier requirements and customer specifications for generics.
Prepare and review regulatory submissions, technical files, and CMC documentation .
Act as primary contact during regulatory audits/inspections and customer audits.
Leadership & Team Management Lead and develop QA/QC teams with strong focus on training and skill enhancement.
Ensure effective cross-functional collaboration between Production, Engineering, R&D, Regulatory, and Supply Chain .
Promote a strong quality culture across the site.
Key Skills & Competencies In-depth knowledge of EU-GMP, ICH guidelines, GLP, WHO GMP, USFDA regulations .
Expertise in formulations (OSD, injectables, suspensions, etc.) and β-lactam manufacturing processes .
Strong understanding of sterility assurance, microbiology, and containment strategies for β-lactam facilities .
Proficient in QMS tools (TrackWise, Veeva, or equivalent).
Strong leadership, decision-making, and problem-solving skills.
Excellent communication for handling regulatory agencies and global clients .
Qualifications & Experience Master’s in Pharmacy / Pharmaceutical Sciences / Chemistry (M.Pharm / M.Sc).
Minimum 10–15 years of experience in pharmaceutical QA, with at least 7 + years in a managerial role .
Hands-on experience in formulations, generics, and β-lactam facilities .
Proven track record of facing EU/MHRA/USFDA inspections .
Salary Range-Not disclosed
Please feel free to connect @ and share your CV at /
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