Website:
sotalent.us
Job details:
Quality Assurance (QA) Expert – Front End (GMP / Engineering Projects)
Location: Hyderabad, India
Industry: Life Sciences / Pharmaceuticals / Biopharma Manufacturing
Work Setting: On-site (Global Engineering & Quality Projects – CAPEX environment)
Role Overview
We are seeking a Quality Assurance (QA) Expert – Front End to act as a strategic quality partner within global engineering and capital investment projects. This role ensures that GMP compliance, regulatory expectations, and Lonza quality standards are embedded from the earliest project phases through design and feasibility.
You will play a critical role in de-risking large-scale CAPEX investments by integrating quality requirements into project design, engineering decisions, and early-stage governance (Stage Gate 0–2).
Key Responsibilities
Quality Integration in Early Projects
- Embed GMP and quality requirements during project initiation and design phases (SG-1 to SG-2)
- Ensure compliance is integrated into business case development and technical planning
CAPEX & Engineering Quality Oversight
- Provide QA oversight for global investment and infrastructure projects
- Support alignment between engineering design, operations requirements, and regulatory expectations
GMP Design Reviews
- Conduct detailed GMP design and documentation reviews
- Ensure facility layouts, systems, and technical specifications meet compliance standards
Stage Gate Governance Support
- SG-0: Validate project feasibility from a quality perspective
- SG-1: Confirm business case and compliance alignment
- SG-2: Review and approve CAPEX/OPEX design concepts
Stakeholder & Cross-functional Collaboration
- Partner with engineering, operations, and senior leadership teams globally
- Provide expert QA guidance to support decision-making and risk mitigation
Compliance & Data Integrity
- Ensure adherence to GMP standards (FDA, EMA, and other global regulations)
- Promote and enforce data integrity principles across all project documentation
Continuous Improvement
- Identify gaps in quality processes and drive improvements in early project governance
- Support ongoing enhancements within Global Quality Engineering (GQE) frameworks
Required Skills & Experience
- Bachelor’s or Master’s degree in Engineering, Pharmaceutical Sciences, Biotechnology, Chemistry, or related field
- Strong experience in GMP-regulated environments (pharma, biotech, life sciences)
- Background in Quality Assurance within engineering, manufacturing, or CAPEX projects
- Experience with GMP standards (FDA, EMA, ICH guidelines)
- Understanding of facility design, qualification processes, or capital project lifecycle
- Strong documentation review and compliance assessment skills
Core Competencies
- Strong GMP and quality systems expertise
- Excellent analytical thinking and attention to detail
- Ability to influence senior stakeholders and cross-functional teams
- Strong collaboration in global, matrix environments
- Risk-based decision-making mindset
- Clear communication of technical and compliance concepts
Role Impact
This role ensures that quality is not an afterthought but a foundational element in global engineering and investment projects. By embedding GMP compliance early in the design phase, you directly contribute to safer, more efficient, and regulatory-compliant manufacturing facilities that support medicines of the future.
Click on Apply to know more.