The role involves leading out of specification investigations and core QMS activities within 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 3–8 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
Cgmp
Fda
Gc
Hplc
Ich
Ir
Kf
Mhra
Polarimeter
Titroprocessor
Uv
Similar Jobs
Pharmaceutical
Lead out of specification investigations and core Quality Management System activities in the pharmaceutical industry, focusing on analytical assurance.
Top Skills:
GcHplcIrPolarimeterTitroprocessor/KfUv
Cloud • Computer Vision • Information Technology • Sales • Security • Cybersecurity
Drive enterprise-wide automation initiatives by designing and implementing solutions using N8N and Tray.ai. Collaborate with teams to automate processes, integrate systems, and ensure high availability of workflows while mentoring others and reporting on impact.
Top Skills:
Gemini EnterpriseJSONMcpN8NPythonRest ApisSQLTray.AiXML
Cloud • Computer Vision • Information Technology • Sales • Security • Cybersecurity
The role involves designing and implementing automation solutions using N8N and Tray.ai, developing AI-powered workflows, and integrating various applications while collaborating with cross-functional teams.
Top Skills:
Ci/CdCoupaDevOpsGemini EnterpriseJSONMcpN8NNetSuitePythonRest ApisSalesforceSAPSnowflakeSQLTray.IoWorkdayXML
What you need to know about the Pune Tech Scene
Once a far-out concept, AI is now a tangible force reshaping industries and economies worldwide. While its adoption will automate some roles, AI has created more jobs than it has displaced, with an expected 97 million new roles to be created in the coming years. This is especially true in cities like Pune, which is emerging as a hub for companies eager to leverage this technology to develop solutions that simplify and improve lives in sectors such as education, healthcare, finance, e-commerce and more.
