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
Artificial Intelligence • Cloud • HR Tech • Information Technology • Productivity • Software • Automation
Lead product strategy in the Workplace Business Unit, focusing on AI integration, team collaboration, and high-quality product delivery. Oversee all phases from concept to launch while fostering innovation and user satisfaction.
Top Skills:
AIFacility Management SoftwareHybrid Work SolutionsIotResource Booking SoftwareServicenow PlatformSpace Planning SoftwareWorkplace Analytics
Cloud • Information Technology • Productivity • Security • Software • App development • Automation
The Senior Engineering Manager will oversee the engineering team, ensuring project delivery, team development, and alignment with company goals.
What you need to know about the Delhi Tech Scene
Delhi, India's capital city, is a place where tradition and progress co-exist. While Old Delhi is known for its rich history and bustling markets, New Delhi is defined by its modern architecture. It's clear the region places a strong emphasis on preserving its cultural heritage while embracing technological advancements, particularly in artificial intelligence, which plays a central role in shaping the city's tech landscape, fueled by investments in research and development.
