QA Executive – Bio Manufacturing | IPCA Labs | Pithampur

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Job Overview

  • Date Posted
  • Location (State / UT)
  • Expiration date
  • Experience
    3 Years, 5 Years
  • Gender
  • Desired Qualification
    Bachelor Degree, Master’s Degree
  • Salary in (₹)

Job Description

  • The quality Assurance specialist is responsible to support for overall Implementation and maintenance of the Quality Management System at Pithampur, Indore.
  • Documentation Management (review, approval, maintenance of documents, and follow-up with SMEs).
  • Review and Approval of all SOPs related to Ipca, Pithampur, Indore
  • Review documents related to CMO.
  • Provide training to QA and other departments as and when required.

Key Responsibilities:

  • Track and carry out CMO activities for Tech transfer and ongoing batches,
  • Responsible for continuous In-process Quality Audit at CMO Site for Ipca batches.
  • Review of Batch Manufacturing Record for CMO site for Ipca.
  • Review of Tech Transfer-related documents such as TTDs, MOAs, Specifications, AMTPs, and MQRs.
  • Conduct an internal audit and audits at CMO.
  • Participate in Vendor/consultant audits

Key Activities:

  • Keeping track and issuance and Retrieval of Lab Note Book, Log Book, Record Book, Batch Process Record books, Key and Tank Book issuance.
  • Archival of Service reports-Breakdown, Calibration Reports.
  • Checking the compliance of SOPs and QA Visits in the Lab.

Qualification/Experience: BSc/MSc in Microbiology with 3 – 4 years of QA experience