PHARMAFull-time
Quality Engineering, QA Expert, Commissioning & Qualification Audit and Inspection Support
HYDERABAD (IN)HYBRIDPOSTED: 9/18/2026
PHARMAFull-time
HIRING ORGANIZATIONLONZALife Sciences / Pharmaceutical Manufacturing / Healthcare Technology
ROLE OVERVIEW
QA Expert role providing Global Quality Engineering oversight for commissioning and qualification, CAPEX projects, audits, inspections, remediation, CAPA, and cGMP compliance.
ROLE DEFINITION & RESPONSIBILITIES
- •Translate regulatory trends and inspection outcomes into quality improvements
- •lead remediation plans from project quality reviews and audit observations
- •coordinate cross-functional corrective actions and assess effectiveness
- •evaluate projects and sites against health authority expectations
- •oversee CAPA lifecycle
- •review and approve technical documentation, risk assessments, and regulatory responses
- •support audits, inspections, and process qualification activities
- •drive data integrity and continuous improvement
Reporting Hierarchy: Reports to Global Quality Engineering Leadership and works cross-functionally with project teams, quality organizations, engineering, manufacturing, regulatory, and other stakeholders.
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Bachelor's or Master's degree in Engineering (Biologics/Chemical) or Biological Sciences
- minimum 5 years in regulated pharmaceutical or biotech industry
- experience in engineering, QA, QC, manufacturing, R&D, or regulatory affairs
- experience with chemical/biological GMP API manufacturing
- knowledge of EMA, FDA, ICH, and PIC/S requirements
- proven management experience in regulated environments
PREFERRED QUALIFICATIONS
- •CQV approaches, facility design quality systems, internal audit planning, API engineering and cGMP manufacturing expertise, risk-based quality systems, project management, team leadership and mentoring
REQUIRED VERIFIED SKILLS
Quality assurance
cGMP
GMP manufacturing
CQV
commissioning
qualification
CAPA
audit support
inspection readiness
risk management
quality systems
data integrity
regulatory compliance
API manufacturing
project management
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Benefits may include professional development, employee wellbeing programs, learning opportunities, and standard corporate benefits; exact benefits vary by location and eligibility.
No salary or monetary bonus amount is disclosed in the supplied posting; compensation should be verified through the official application process.
ORGANIZATION CONTEXT & CULTURE
Lonza is a global life-sciences manufacturing and development company supporting pharmaceutical and biotechnology customers, with more than 30 sites across five continents.
TEAM SIZE: 30+ sites globally
INDUSTRY: Life Sciences / Pharmaceutical Manufacturing / Healthcare Technology
Culture: Collaboration, accountability, excellence, passion, and integrity are emphasized, with a focus on inclusion, innovation, professional development, and high-quality execution.
EXPECTED CAREER ROADMAP
Provides opportunities to progress into senior Global QA, Quality Engineering, CQV quality leadership, audit/inspection leadership, or broader quality management roles within regulated pharmaceutical and biotech operations.
APPLICATION ADVISORY
Emphasize 5+ years of regulated pharma/biotech experience, cGMP API manufacturing, quality engineering or QA expertise, CQV, CAPA, audit and inspection readiness, regulatory knowledge, and experience leading cross-functional remediation. Highlight leadership and risk-based quality-system experience.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
Verify your capability profile and matching credentials before submitting direct applications.