CQV

Incepbio ✓ Verified

Bengaluru, KA

Job Description

Key Responsibilities

1. CQV Execution & Documentation

Prepare, review, and execute URS, DQ, FAT/SAT, and IQ/OQ/PQ protocols and summary reports.
Perform equipment and utility qualification testing according to approved site procedures.
Ensure data integrity, traceability, and strict adherence to GDP (Good Documentation Practices).
Support test script development for mechanical, electrical, automation, and process systems.
Participate in system risk assessments, change controls, and deviation management.

2. Quality & Compliance

Verify systems meet design and regulatory expectations prior to handover for GMP manufacturing.
Support internal/external quality audits with technical documentation and explanations.
Contribute to continuous improvement of CQV templates and standard procedures.

3. Project & Stakeholder Management

Act as technical point-of-contact for assigned systems, reporting progress and risks to project leads.
Coordinate with third-party vendors, contractors, and client teams (QA, Facilities, Engineering).
Strictly follow client EHS, quality, and data security guidelines.

Key Requirements

Education: B.E. / B.Tech / M.Tech in Mechanical, Chemical, Bio-Engineering, or related fields.
Experience: Hands-on CQV / validation experience in pharma, biotech, or sterile manufacturing facilities.
Knowledge: Direct working experience with EU Annex 15, ISPE Baseline Guides, and 21 CFR Part 11.