Lonza is hiring for the position of QA Specialist, QC and Laboratory Equipment Qualification at its Hyderabad, India location. The role is part of Lonza’s global Quality organization and focuses on Quality Assurance oversight of QC laboratory equipment qualification, GMP compliance, data integrity, and equipment lifecycle management.
Candidates with experience in pharmaceutical or biotechnology quality assurance, GMP, QC laboratory operations, validation, and equipment qualification can apply.
Job Details
| Particulars | Details |
|---|---|
| Company | Lonza |
| Job Role | QA Specialist, QC and Laboratory Equipment Qualification |
| Job Location | Hyderabad, India |
| Job Type | Full Time |
| Job Requisition ID | R80672 |
| Work Mode | Primarily On-site |
| Remote Work | Up to 20% |
| Relocation Assistance | Available for eligible candidates and their families |
| Qualification | Bachelor’s or Master’s Degree |
| Job Category | Quality Assurance (QA), Quality Control (QC) |
Position
QA Specialist, QC and Laboratory Equipment Qualification
The selected candidate will provide Quality Assurance oversight for laboratory equipment qualification activities, ensuring compliance with GMP, regulatory requirements, and data integrity principles.
Key Responsibilities
- Provide QA oversight for QC and laboratory equipment qualification activities.
- Review and approve qualification documents, including risk assessments, protocols, reports, deviations, CAPAs, change controls, and periodic reviews.
- Support equipment lifecycle management, including qualification, requalification, change assessments, and inspection readiness.
- Collaborate with QC laboratories, Validation and Qualification SMEs, Automation/CSV Engineers, Engineering, and Quality teams.
- Provide QA guidance during qualification execution.
- Ensure appropriate management of quality events and deviations.
- Identify compliance risks and drive continuous improvement initiatives.
- Strengthen qualification processes, documentation standards, and data integrity practices.
- Support global qualification and quality excellence programs as a subject matter expert.
Eligibility and Qualifications
Candidates should meet the following requirements:
- Bachelor’s or Master’s degree in a science-related discipline or engineering field.
- Experience in pharmaceutical or biotechnology environments.
- Experience in GMP Quality, QC laboratory operations, validation, qualification, or technical compliance.
- Understanding of QC laboratory workflows and qualified laboratory equipment used to generate reliable GMP data.
- Practical experience across the equipment qualification lifecycle.
Required Skills and Technical Knowledge
- cGxP and GMP compliance.
- GMP documentation practices.
- Good Documentation Practices (GDocP) and cGDP.
- Data integrity principles.
- User Requirements Specification (URS).
- Risk assessments.
- Installation Qualification (IQ).
- Operational Qualification (OQ).
- Performance Qualification (PQ).
- Equipment requalification and periodic reviews.
- Change impact assessments.
- Qualification documentation review.
- Deviation and CAPA management.
- Analytical and problem-solving skills.
- Stakeholder management and communication.
Work Environment and Benefits
The position is primarily based on-site in Hyderabad, with remote work flexibility of up to 20% of working time. Remote work requests are considered on a case-by-case basis according to business requirements.
Lonza offers:
- Opportunities to work with global quality, validation, and laboratory experts.
- Exposure to laboratory technologies and qualification programs.
- Continuous learning and professional development.
- Compensation programs recognizing high performance.
- An inclusive and ethical workplace.
- Relocation assistance for eligible candidates and their families.