Role & responsibilities

Key Responsibilities

* Lead the QA Validation function and ensure compliance of all validation activities with cGMP and global regulatory requirements.

* Provide Quality oversight for commissioning, qualification (DQ/IQ/OQ/PQ), and validation of facilities, utilities, equipment, and computerized systems.

* Review and approve validation protocols, reports, risk assessments, and Validation Master Plans.

* Partner with Engineering and Projects to ensure GMP compliance during design, installation, qualification, and startup of new manufacturing facilities.

* Oversee process validation, cleaning validation, computer system validation (CSV), and analytical method validation activities.

* Review validation impact assessments for change controls, deviations, CAPAs, and engineering modifications.

* Support technology transfer, regulatory inspections, and customer audits related to validation and qualification.

* Lead, mentor,



and develop the QA Validation team while driving continuous improvement and inspection readiness across the site.

- Ensure risk-based lifecycle validation for GxP systems including:
- DCS/PLC/ SCADA
- QC Lab systems: LIMS. E logbooks.
- Quality Systems like Veeva, eQMS, Track wise
- IT Infrastructure support

- Ensure 21 CFR part 11 and Annex 11 compliance and inspection readiness.
- Develop and approve URS, FS,DS,RA,IQ,OQ&PQ;, traceability matrices and validation summary reports.
- Qualify and manage CSV vendors
- Work closely with Manufacturing, QC, IT, Automation , Engineering and QA teams.

Preferred candidate profile

Experience & Education: 15-20 years masters in science/ pharmacy / biotechnology /microbiology /M Pharm

Should have experience of working in biologics manufacturing companies (Experience of validation /qualification of DS and DP equipment).

*Experience of working with international clients will be practical.

📌 AGM -Validation and Qualification (Hyderabad)
🏢 CuraTeQ Biologics
📍 Hyderabad