Biochemistry Jobs at Lonza | Candidates Apply Now
Are you looking for Biochemistry Jobs, QA Jobs, or exciting opportunities through Lonza Careers in Hyderabad? Lonza is hiring a QA Qualification Specialist for its Hyderabad location. Candidates with experience in GMP compliance, qualification, validation, and regulated pharmaceutical environments are encouraged to apply for this excellent opportunity in the pharmaceutical and biochemistry industry.
About Lonza
Lonza is a globally recognized pharmaceutical and biotechnology company known for delivering innovative healthcare and life sciences solutions. The company specializes in biologics, cell and gene technologies, and pharmaceutical manufacturing services. Through continuous innovation and high-quality standards, Lonza Careers offers excellent opportunities for professionals seeking growth in Biochemistry Jobs, QA Jobs, and pharmaceutical industry careers.
Key Responsibilities
- Commissioning & Qualification Lifecycle
- Review and approve reports, protocols, and test documentation for commissioning and qualification activities.
- Handle the qualification of facilities, utilities, computerized systems, equipment, and laboratories in line with Lonza standards and regulatory expectations.
- GMP Design Review
- Support review of GMP design deliverables, including flows, zoning, and layouts, to ensure compliance.
- Deviation Management
- Ensure discrepancies or deviations related to facilities and utilities are assessed, documented, traceable, and resolved.
- Periodic Requalification & Validation Maintenance
- Review and approve periodic requalification documentation for freezers, autoclaves, HVAC systems, biosafety cabinets, and cold rooms.
- Confirm validated state through validation maintenance reports.
- Review and approve decommissioning documentation where applicable.
- Quality & Risk Management
- Review and support management of quality records, including deviations, CAPA, change controls, investigations, and product quality review.
- Maintain GMP compliance, technical accuracy, and documentation quality.
- Audit Readiness
- Promote and maintain audit readiness across qualification activities.
- Timely Delivery
- Deliver assigned work within agreed timelines while proactively escalating risks and delays.
- Continuous Improvement
- Support process improvement initiatives and the implementation of new tools or approaches.
- Other Duties
- Perform additional quality and compliance-related responsibilities as assigned.
Qualifications
- Bachelor’s degree in Chemistry, Biochemistry, Pharmacy, or related scientific field.
- Strong understanding of GMP requirements and regulatory standards.
- Knowledge of EMA/FDA-regulated environments.
- Familiarity with ICH, PIC/S, EU, and US regulatory requirements.
- Knowledge of CQV approaches and electronic validation tools such as Kneat Gx.
Experience Required
- Minimum 5 years of relevant experience in a regulated pharmaceutical industry.
- Experience in engineering, manufacturing, QA, or QC environments.
- Hands-on experience in commissioning, qualification, and validation of manufacturing equipment, facilities, utilities, laboratory equipment, and computerized systems.
- Experience in process validation or cleaning validation is beneficial.
- Experience in chemical and biological GMP API manufacturing environments.
Skills Needed
- Strong analytical and problem-solving skills.
- Excellent communication skills in an international environment.
- Self-starter with a solution-driven mindset.
- Strong teamwork and collaboration abilities.
- Experience with process mapping and performance analysis is desirable.
- Proficiency in Microsoft Office and Power BI.
- Excellent spoken and written English skills.
- German language skills are desirable.
Candidates looking for Biochemistry Jobs, QA Jobs, and exciting opportunities through Lonza Careers should not miss this excellent QA Specialist Qualification role in Hyderabad. Apply now and build your future with a leading global pharmaceutical company.
