QE Specialist

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.

Responsibilities:

• Provide real-time QA oversight on the production floor, in warehouse areas, and during qualification activities.
• Perform batch record and logbook review, ensuring accuracy, completeness, and compliance with GDP standards.
• Execute and document line clearance and room readiness inspections prior to manufacturing activities.
• Review qualification and validation protocols for clarity, compliance, and alignment with regulatory and internal quality expectations.
• Support execution of qualification protocols by providing on-site quality presence during testing and ensuring deviations are properly documented and escalated. 6. Initiate, investigate, and support closure of deviations, non-conformances, and CAPAs related to manufacturing and qualification activities.
• Collaborate with cross-functional teams to ensure timely and compliant execution of commissioning, qualification, and validation activities.
• Support the development and maintenance of site-specific quality procedures (SOPs, work instructions, forms) governing manufacturing, warehousing, engineering, maintenance, and validation operations.
• Review and approve site procedures to ensure clarity and compliance with cGMP standards.
• Maintain awareness of site policies, cGMP regulations, and evolving regulatory expectations applicable to sterile injectable operations.
• Participate in internal walkthroughs, audit preparations, and readiness activities for regulatory inspections.
• Support the implementation of continuous improvement initiatives and site quality metrics.

Requirements:

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