Assistant Manager - Ipqa

Lambda CRO

Ahmedabad, India
On-site
Batch record review
Documentation adherence
Quality management system
Lambda Therapeutic Research Ltd. is positioning the “Contract Development & Manufacturing Organization (CDMO)” in its vision to serve as an integrated solutions provider for biologics drug development, GMP manufacturing, and to enable First in Human (FIH) clinical trials globally

Job Summary

  • Lambda Therapeutic Research Ltd. is positioning the “Contract Development & Manufacturing Organization (CDMO)” in its vision to serve as an integrated solutions provider for biologics drug development, GMP manufacturing, and to enable First in Human (FIH) clinical trials globally.
  • Will be responsible for review of batch records and log books, filling in various applicable formats, including line clearance and sampling formats, along with batch records review sheets.
  • Will be tasked with checking the adherence to the Quality Management System (QMS) elements, such as change control, incident management, and CAPA (Corrective and Preventive Actions) management on the shop floor.

Matching Summary

Lambda Therapeutic Research Ltd. is positioning the “Contract Development & Manufacturing Organization (CDMO)” in its vision to serve as an integrated solutions provider for biologics drug development, GMP manufacturing, and to enable First in Human (FIH) clinical trials globally.

Skills & Requirements

Must-have

  • batch record review
  • documentation adherence
  • Quality Management System
  • GMP requirements verification
  • incident reporting system

Nice-to-have

  • agile collaborative approach
  • end-to-end support
  • investigation support

Key Requirements

  • 7 years of industrial experience
  • B.Pharm. or Post-Graduation
  • Microbiology/Quality Assurance/Biochemistry/Biotechnology

Work Rights

Not specified

Tailored Resume

Cover Letter