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
Cloud • Information Technology • Security • Software
The Staff Quality Engineer will lead quality initiatives, engage in SDLC processes, architect testing strategies, and mentor teams in quality standards and automation.
Top Skills:
AWSCypressGherkinPytestPython
Cloud • Fintech • Information Technology • Machine Learning • Software • App development • Generative AI
The Billing Specialist manages daily billing operations including invoice preparation, account maintenance, and resolving billing inquiries while collaborating across departments to ensure accuracy and process improvements.
Top Skills:
ExcelNetSuiteSalesforce BillingSalesforce CpqZuora
Cloud • Fintech • Information Technology • Machine Learning • Software • App development • Generative AI
As Senior Manager of Engineering, you will lead and inspire software development teams, manage Agile processes, and enhance SaaS applications while providing technical leadership and mentoring.
Top Skills:
C#C++Google Cloud PlatformHadoopHiveJavaNifiSpark
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.
