Company: Shilpa Biologicals
Location: Hubli-Dharwad, Karnataka
Experience: 2–7 Years
Qualification: B.Pharm / M.Pharm / M.Sc (or related field)
Positions: 2
Salary Range: ₹3–8 LPA
About the Role
Shilpa Biologicals seeks experienced professionals in Quality Assurance (Validation & Computer System Validation) to ensure compliance with regulatory standards (e.g., 21 CFR Part 11, Annex 11) for pharmaceutical equipment and systems.
Key Responsibilities
- Equipment Validation:
- Develop/execute protocols (IQ/OQ/PQ) for autoclaves, depyrogenation tunnels, filling machines, stability chambers, and dry heat sterilizers.
- Validate HVAC systems (AHUs, LAF units, isolators, biosafety cabinets).
- Computer System Validation (CSV):
- Prepare CSV protocols for GxP systems.
- Conduct audit trail reviews to ensure data integrity.
- Documentation:
- Prepare Requirement Traceability Matrices (RTM) and Validation Summary Reports (VSR).
Qualifications & Skills
- 2–7 years in pharmaceutical validation/CSV.
- Expertise in GxP guidelines and regulatory compliance.
- Strong analytical and documentation skills.
Employee Benefits
- Medical & accidental insurance.
- Relocation allowance.
- Two Saturdays off monthly.
- Canteen & transportation facilities.
How to Apply
Send your resume to:
Email: asasidharan@shilpabio.com
Join Shilpa Biologicals to advance your career in pharmaceutical quality assurance!
Shilpa Biologicals is an equal-opportunity employer committed to innovation in pharma.
