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QA Validation
We're Hiring: QA Validation
As a QA Validation Executive, you will play a pivotal role in upholding our quality systems by overseeing validation activities related to equipment, processes, cleaning, utilities, and computerized systems. You will ensure compliance with global regulatory standards and contribute to the integrity of our oncology manufacturing operations.
- Location: Shameerpet
- Department: Quality Assurance
- Qualification: B.Pharm / M.Pharm / M.Sc
- Experience: 3–8 Years (preferably in oncology manufacturing)
Key Responsibilities:
🔹 Validation Protocol Development:
Prepare, review, and execute validation protocols (IQ, OQ, PQ) for manufacturing equipment, HVAC, water systems, cleanrooms, and utilities.
🔹 Process & Cleaning Validation:
Plan and conduct process validation and cleaning validation as per current regulatory expectations and internal SOPs.
🔹 Documentation & Reporting:
Prepare validation reports, maintain traceable documentation, and ensure alignment with GMP and data integrity principles.
🔹 Cross-functional Collaboration:
Work closely with Production, QC, Engineering, and Regulatory Affairs to implement robust validation strategies.
🔹 Audit & Regulatory Readiness:
Support external audits (USFDA, EU, WHO, etc.) and internal inspections by maintaining audit-ready documentation.
🔹 Risk Assessment & Change Control:
Participate in risk assessments, deviation investigations, and review of change controls related to validated systems.
Technical Competencies
- Sound understanding of cGMP, ICH Q8–Q11, WHO TRS, and USFDA guidelines.
- Proficiency in drafting protocols, reports, and validation master plans.
- Knowledge of cleaning validation, hold time studies, and analytical method validation.
- Familiarity with data integrity and ALCOA+ principles.
Qualifications:
B.Pharm / M.Pharm / M.Sc. in Pharmacy, Chemistry, Biotechnology, or related discipline.
3 to 8 Years (preferably in oncology manufacturing)