Are you an experienced professional in Computerized System Validation (CSV) looking for a rewarding opportunity in the pharmaceutical industry? SCL Lifesciences, a leader in pharmaceutical innovation, is hiring for a Quality Assurance (CSV) Specialist at our state-of-the-art facility in Derabassi, Punjab. This role offers a chance to contribute to cutting-edge validation processes while advancing your career in a dynamic environment. Join us to ensure compliance with industry standards and drive excellence in pharmaceutical quality assurance.
Key Responsibilities
As a Quality Assurance (CSV) Specialist at SCL Lifesciences, you will:
- Perform Computerized System Validation (CSV) for software and analytical equipment, ensuring compliance with regulatory guidelines.
- Develop and execute validation lifecycle processes, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Create and review critical documentation such as User Requirement Specifications (URS), Design Qualification (DQ), and Functional Requirement Specifications (FRS).
- Conduct risk assessments, root cause analysis, and implement corrective actions to maintain system integrity.
- Collaborate with cross-functional teams to support project management and ensure seamless system configurations.
- Utilize tools like Labware, ERP, EMPOWER, MINITAB, HPLC, and CHROMELEON for validation and data analysis.
- Ensure adherence to industry standards and regulatory requirements throughout the validation process.
Qualifications
To excel in this role, you should have:
- 5–7 years of experience in Computerized System Validation (CSV) within the pharmaceutical or biotech industry.
- Strong knowledge of CSV deliverables, SDLC, and IT infrastructure.
- Proficiency in validation tools and software, including Labware, ERP, EMPOWER, MINITAB, HPLC, and CHROMELEON.
- Expertise in validation lifecycle processes (IQ, OQ, PQ) and documentation (URS, DQ, FRS).
- Excellent project management and cross-functional collaboration skills.
- Strong analytical skills for root cause analysis and defect tracking.
- Familiarity with regulatory guidelines and industry standards in pharmaceutical validation.
Benefits
Joining SCL Lifesciences offers:
- Competitive salary range of INR 8,00,000–12,00,000 per annum, commensurate with experience.
- Opportunities for professional growth in a leading pharmaceutical company.
- Access to cutting-edge tools and technologies in a modern facility.
- Collaborative and inclusive work environment in Derabassi, Punjab.
- Comprehensive health and wellness benefits.
How to Apply
Ready to take the next step in your career? Submit your resume and a cover letter to manik.mehta@scllifesciences.com. Ensure your application highlights your experience in Computerized System Validation (CSV) and relevant skills. Applications are reviewed on a rolling basis, so apply by November 24, 2025, to be considered.
FAQs
Q: What is the application deadline for the Quality Assurance (CSV) role?
A: The application deadline is November 24, 2025. Early applications are encouraged as we review on a rolling basis.
Q: What tools are essential for this role?
A: Proficiency in Labware, ERP, EMPOWER, MINITAB, HPLC, and CHROMELEON is critical for success in this position.
