Mechanical Quality Assurance (QA) Engineer

Company Description

Welcome to Vroutes HR, your trusted global partner for comprehensive HR solutions and business consulting services! Established in 2017 and headquartered in Hyderabad, Telangana, India and servicing globally with 4+ Branches, we are dedicated to redefining HR solutions and business consulting on a global scale. Our tailored services are designed to align with your unique goals, offering a holistic approach to HR and business management. With a focus on delivering end-to-end services in Human Resource & Business Consulting , we offer a 360-degree approach to cater to your diverse needs and aspirations. We provide a wide range of offerings, including: HR Operations Services Strategic HR Services HR Business Partnering Performance Management Training and Development Reward and Recognition Compensation and Benefits Consulting HR Documentation Design and Drafting HR Shared Services (Employee Lifecycle) HR Audit and Compliance Virtual HR Services SOP and Process Flow Development HR Policy Design and Drafting At Vroutes HR, we combine expertise with innovation to drive your organization's success. Let us help you navigate the complexities of HR and business management efficiently and effectively. Contact us today to learn more about how we can support your business growth and HR Excellence [Vroutes Strategic Consulting LLP (formerly known as VROUTES)]

Job Description

We are seeking a Quality Assurance Engineer with experience in lyophilization systems to ensure compliance, validation, and quality excellence across equipment and processes. The role will involve working across the equipment lifecycle, including exposure to Design Qualification (DQ) and Factory Acceptance Testing (FAT), along with core QA responsibilities.

Key Responsibilities:

• Support preparation and review of qualification documents including DQ, IQ, OQ, and PQ
• Participate in Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) activities
• Ensure compliance with GMP, GLP, and regulatory requirements (FDA, WHO, EU)
• Review batch records, SOPs, and validation documentation
• Handle deviations, CAPA, and change control processes
• Collaborate with Engineering, Production, and Vendors for equipment qualification and process improvement
• Ensure traceability across URS, DQ, FAT, SAT, and validation lifecycle
• Support audits and regulatory inspections
• Maintain documentation integrity and quality standards

Qualifications

Required Qualifications:

• Bachelor’s/Master’s in Pharmacy, Chemical Engineering, Biotechnology, or related field
• 3–7 years of experience in QA within pharmaceutical/biotech manufacturing
• Experience with lyophilization (freeze-drying) systems
• Working knowledge of equipment qualification and validation processes

Key Skills:

• Understanding of validation lifecycle (URS to PQ)
• Exposure to DQ documentation and FAT participation
• Strong knowledge of GMP and quality systems
• Attention to detail and documentation excellence
• Good cross-functional coordination and communication skills

Additional Information