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 • Information Technology • Productivity • Security • Software • App development • Automation
As a Senior Product Security Engineer, you will enhance security programs, build automated tools, and collaborate with development teams to secure applications and architecture.
Top Skills:
AWSAzureGCPGoJavaPython
Cloud • Information Technology • Productivity • Security • Software • App development • Automation
As a Senior Machine Learning Engineer, you will build and scale machine learning models, write performant code, and communicate complex ideas effectively, while focusing on agile development and iterative improvements.
Top Skills:
AWSDatabricksJavaPythonSparkSQL
What you need to know about the Chennai Tech Scene
To locals, it's no secret that South India is leading the charge in big data infrastructure. While the environmental impact of data centers has long been a concern, emerging hubs like Chennai are favored by companies seeking ready access to renewable energy resources, which provide more sustainable and cost-effective solutions. As a result, Chennai, along with neighboring Bengaluru and Hyderabad, is poised for significant growth, with a projected 65 percent increase in data center capacity over the next decade.
