Lead out of specification investigations and core Quality Management System activities in the pharmaceutical industry, focusing on analytical assurance.
Job Title: Executive / Sr. Executive - Quality Management System (Analytical Assurance)
Department: Quality Management System
Reports to: Manager
Location: Ankleshwar
Position Type: Full-time
Qualifications and Experience:
- Education: B.Pharm / M.Pharm / M.Sc in Chemistry, Biotechnology, or related field.
- Experience: Minimum 6–8 years of experience in Analytical Assurance within the pharmaceutical industry
Job Responsibilities & Accountabilities:
We are looking for an experienced Analytical Assurance professional to join our team and lead the Out of specification investigation, along with core QMS activities pertaining to QC.
Key Responsibilities:
- Trigger out of specification investigations upon detection of test results outside predefined specifications. Design and execute tests to confirm or rule out suspected root causes.
- Handling QMS documents i.e., Incidents & Deviations
- To evaluate change control & CAPA
- To review analytical documents i.e. worksheet, specification, method of analysis, stability protocol & summary report and logbook etc. of Quality Control department.
- To review & approve stability protocol
What We’re Looking For:
- 6-8 years of Analytical Assurance experience in pharmaceutical manufacturing (formulations)
- Ability to investigate issues, understand root causes, and suggest effective solutions
- Expertise in analytical techniques (e.g., HPLC, GC, UV, Polarimeter, Titroprocessor/KF, IR).
- Strong understanding of CGMP, FDA, MHRA, and ICH guidelines
Top Skills
Gc
Hplc
Ir
Polarimeter
Titroprocessor/Kf
Uv
Similar Jobs
Artificial Intelligence • Edtech • Mobile • Natural Language Processing • Productivity • Software
The role involves designing, developing, and maintaining full-stack applications focused on user retention and growth, collaborating with cross-functional teams, and optimizing systems to impact millions of users.
Top Skills:
AmplitudeGa4JavaScriptMixpanelNode.jsNoSQLReactSQLTypescript
Machine Learning • Natural Language Processing
Join a community of linguists and contribute to AI through annotation, evaluation, and prompt creation in a flexible, remote role.
Top Skills:
Digital Tools
Artificial Intelligence • Cloud • Information Technology • Sales • Security • Software • Cybersecurity
The Software Engineer II will develop and maintain security solutions, collaborate with teams, mentor juniors, and ensure product quality.
Top Skills:
AWSGithub ActionsGoJavaJenkinsJunitMavenPythonSpring Boot
What you need to know about the Bengaluru Tech Scene
Dubbed the "Silicon Valley of India," Bengaluru has emerged as the nation's leading hub for information technology and a go-to destination for startups. Home to tech giants like ISRO, Infosys, Wipro and HAL, the city attracts and cultivates a rich pool of tech talent, supported by numerous educational and research institutions including the Indian Institute of Science, Bangalore Institute of Technology, and the International Institute of Information Technology.
