What are the responsibilities and job description for the QE Specialist position at WhiteCrow Research?
About WhiteCrow
We are global talent research, insight, and sourcing 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 talent acquisition teams.
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.
As a QE Specialist, you will be responsible for...
- Providing real-time QA oversight on the production floor, in warehouse areas, and during qualification activities.
- Performing batch record and logbook review, ensuring accuracy, completeness, and compliance with GDP standards.
- Executing and documenting line clearance and room readiness inspections prior to manufacturing activities.
- Reviewing qualification and validation protocols for clarity, compliance, and alignment with regulatory and internal quality expectations.
- Supporting execution of qualification protocols by providing on-site quality presence during testing and ensuring deviations are properly documented and escalated.
- Initiating, investigating, and supporting closure of deviations, non-conformances, and CAPAs related to manufacturing and qualification activities.
- Collaborating with cross-functional teams to ensure timely and compliant execution of commissioning, qualification, and validation activities.
- Supporting the development and maintenance of site-specific quality procedures (SOPs, work instructions, forms) governing manufacturing, warehousing, engineering, maintenance, and validation operations.
- Reviewing and approving site procedures to ensure clarity and compliance with cGMP standards.
- Maintaining awareness of site policies, cGMP regulations, and evolving regulatory expectations applicable to sterile injectable operations.
- Participating in internal walkthroughs, audit preparations, and readiness activities for regulatory inspections.
- Supporting the implementation of continuous improvement initiatives and site quality metrics.
What you already have...
Qualifications/Experience:
- Bachelor’s degree in a scientific, engineering, or technical discipline (e.g., Biology, Chemistry, Pharmacy, Engineering)
- 2–5 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 is strongly preferred
- Familiarity with GDP, batch record review, and deviation documentation processes
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
- Comfortable supporting shop-floor activities and cross-functional execution teams
- 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