What are the responsibilities and job description for the Quality Engineer position at WhiteCrow Research?
About WhiteCrow
We are global talent research, insight and pipelining specialists with offices in the UK, USA, Singapore, Malaysia, Hong Kong, Dubai, and India. Our international reach has helped us to understand and penetrate specialist markets at a global level. In addition to this, our service is also extended to complement our client’s in-house research.
About our client
Our client is a global injectables company headquartered in Bengaluru, India, with a strong presence across Asia, Europe, and the USA, and is expanding rapidly into new markets. The company focuses on developing value-added sterile injectables that address critical gaps in healthcare delivery.
By enhancing hospital workflows, reducing wastage of key resources, and improving operational efficiency, our client plays a vital role in supporting healthcare professionals. A robust and reliable supply chain further ensures consistent access to essential medications for patients worldwide.
About the role
The Quality Engineer plays a critical role in supporting qualification activities to ensure compliance with cGMP standards and internal procedures for sterile injectable IV bag products at a newly established greenfield pharmaceutical manufacturing facility. Reporting to the Operations Quality Supervisor, this role will support quality assurance activities including batch record review, line clearance, deviation initiation, protocol review, and support during execution of qualification and validation protocols. The incumbent will work cross-functionally with manufacturing, engineering, and validation teams to ensure documentation integrity, inspection readiness, and adherence to quality system requirements.
As a Quality Engineer, you will be responsible for...
- Acting as technical expert and providing QA support during facility, utility, manufacturing equipment, and laboratory instrument qualification by reviewing qualification and validation protocols for clarity, compliance, and alignment with regulatory and internal quality expectations. Collaborate with cross-functional teams to ensure timely and compliant execution of commissioning, qualification, and validation activities
- Reviewing and approving qualification protocols and final reports (equipment, utilities, facilities, processes) to ensure alignment with quality and regulatory standards.
- Supporting execution of qualification protocols by providing on-site quality presence during testing and ensuring deviations are properly documented and escalated
- Providing QA support during technical transfer and process validation of new products.
- Providing support to operation during Change Control and Deviation process.
- Driving timely and compliant resolution of deviations, non-conformances, and CAPAs arising during operations and qualification activities.
- Supporting the development and maintenance of site-specific quality procedures (SOPs, work instructions, forms) governing manufacturing, warehousing, engineering, maintenance, and validation operations.
- Maintaining awareness of site policies, cGMP regulations, and evolving regulatory expectations applicable to sterile injectable operations.
- Providing QA support during regulatory inspection. Participate in internal walkthroughs, and audit.
- Preparing quality and compliance metrics to support continuous improvements
What you already have...
Qualifications/Experience
- Bachelor’s degree in a scientific, engineering, or technical discipline (e.g., Biology, Chemistry, Pharmacy, Engineering)
- Minimum of 7-10 years of experience in quality assurance, manufacturing, or validation in a cGMP-regulated pharmaceutical or biotech manufacturing environment
- Working knowledge of FDA, EU, and ICH guidelines related to sterile manufacturing, validation, and data integrity
- Experience supporting commissioning and qualification activities
- Ability to work collaboratively with operations, engineering, and validation stakeholders
Skills/Competencies
- Strong attention to detail and commitment to compliance
- Solid written and verbal communication skills
- Ability to work collaboratively across departments in a fast-paced environment
- Strong knowledge of validation principles and qualification documentation
- Proficient in using quality systems and document management tools
- Flexible and adaptable to changing priorities and evolving project timelines
- Commitment to data integrity, continuous improvement, and patient safety