Lonza
Pharmaceutical
QualityEngineering,QASpecialist,ProjectDelivery(CQ&CSV)
Neural analysis suggests this role is
optimal for Mid candidates.
“Quality Engineering, QA Specialist, Project Delivery (CQ & CSV) at Lonza. Skills: Qualification, Validation, Compliance, Project Delivery. Ensure qualification and validation compliance. Review and approve protocols and reports”
What You'll Achieve.
Safeguard Lonza’s adherence to global quality standards; Safeguard adherence to regulatory expectations; Drive consistency across CAPEX projects; Maintain compliance consistency; Support inspection readiness; Support audit activities
Industry & Context.
analytical and problem-solving skills; proactive approach to compliance and risk management
What They're Looking For.
Must Have
Bachelor’s or Master’s degree in Engineering (Biologics or Chemical) or Biological Sciences, background in qualification, validation, and compliance within a regulated pharmaceutical environment, Experience with GMP regulations and global quality standards, Solid understanding of commissioning, qualification, and validation processes for equipment and computerized systems, analytical and problem-solving skills with a proactive approach to compliance and risk management, Excellent communication and stakeholder management skills, with the ability to represent QA in cross-functional teams, Business fluent in English
What You'll Do.
Ensure qualification and validation compliance
Review and approve protocols and reports
Provide guidance on cGMP
Assess impact of regulations
Act as Global QA voice
Support Project Quality Reviews
Contribute to internal audits
Review and approve documentation
Uphold data integrity principles
Translate regulatory trends
Harmonize commissioning standards
Harmonize qualification standards
How You'll Work.
Team & Collaboration
Represent Global QA in cross-functional teams; Work closely with Global Quality Engineering Project Delivery; Work closely with internal teams
Communication Scope
Excellent communication; Stakeholder management
Process & Methodology
Project Delivery, CAPEX projects
Full Job Description
**Quality Engineering, QA Expert – Project Delivery (CQ & CSV)** **Location:** Hyderabad, India **Job Summary:** As a QA Expert in Project Delivery, you will ensure qualification and validation compliance of equipment and computerized systems used in cGMP pharmaceutical manufacturing. This role provides quality guidance to project teams, translates regulatory requirements into actionable strategies, and represents Global QA in cross-functional initiatives. By overseeing commissioning, qualification, and validation activities, you will safeguard Lonza’s adherence to global quality standards and regulatory expectations while driving consistency across CAPEX projects. **Key Responsibilities:** * **Qualification & Validation Compliance:** Ensure qualification and validation plans for equipment and computerized systems meet Lonza’s quality standards and regulatory requirements. Review and approve commissioning, qualification, and validation protocols and reports. * **Regulatory & Compliance Oversight:** Provide guidance on cGMP and regulatory requirements (e.g., FDA, Swissmedic), assessing the impact of new or revised regulations on project delivery. * **Global QA Representation:** Act as the voice of Global QA in cross-functional teams, ensuring quality compliance and alignment with Lonza’s global engineering standards. * **Project Quality Reviews:** Support execution of Project Quality Reviews (PQRs) and contribute to internal audits across CAPEX projects to maintain compliance consistency. * **Documentation & Audits:** Review and approve technical documentation, risk assessments, and regulatory responses. Support inspection readiness and audit activities for growth projects. * **Data Integrity:** Uphold Lonza’s data integrity principles by proactively evaluating, identifying, and improving processes. * **Continuous Improvement:** Translate regulatory trends and inspection outcomes into actionable quality improvements for CAPEX projects. * **Collaboration:** Work close
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