QC Chemist

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.

Role Description:

• The QC Chemist will be a critical member of the laboratory team responsible for performing analytical testing to ensure the quality, safety, and compliance of sterile injectable IV bag products at a newly established greenfield pharmaceutical manufacturing facility.
• This role will support the development, validation, and execution of analytical methods, ensure timely release of raw materials, in-process samples, and finished products, and maintain strict adherence to cGMP, FDA, and global regulatory standards.
• The QC Chemist will play a key role in establishing laboratory operations during the startup phase and sustaining high standards of laboratory excellence throughout routine commercial production.

Responsibilities:

• Perform analytical testing of raw materials, in-process samples, stability samples, and finished products using validated methods (e.g., HPLC, GC, UV-Vis, FTIR, TOC, etc.).
• Develop and validate new analytical methods as required to support product development, regulatory submissions, and process optimization.
• Ensure compliance with cGMP, FDA, USP, and other regulatory standards in all laboratory activities, documentation, and data integrity.
• Prepare and review laboratory documentation including test protocols, reports, COAs, deviations, OOS investigations, and change control documentation.
• Maintain laboratory instruments, perform routine calibrations, troubleshooting, and coordinate with vendors for preventive maintenance and repairs.
• Support laboratory readiness for regulatory inspections, audits, and customer visits by maintaining audit-ready documentation and laboratory practices.
• Assist in the preparation and execution of laboratory investigations, CAPA implementation, and root cause analysis for any analytical deviations.
• Collaborate with cross-functional teams including Manufacturing, Quality Assurance, Validation, and Regulatory Affairs to ensure seamless batch release and product compliance.
• Participate in training programs to ensure technical competency and adherence to evolving regulatory requirements.
• Contribute to continuous improvement initiatives focused on laboratory efficiency, data integrity, and compliance robustness.

Requirements:

Qualifications/Experience:

• Bachelor’s or master’s degree in chemistry, Pharmaceutical Sciences, or related field.
• 3+ years of experience in pharmaceutical QC laboratory, preferably in sterile injectable manufacturing.
• Strong hands-on experience with analytical instrumentation (HPLC, GC, UV, FTIR, etc.) and GMP-compliant laboratory operations.
• Knowledge of FDA cGMP regulations, USP standards, ICH guidelines, and data integrity expectations.
• Experience supporting laboratory investigations and regulatory inspections.

Skills/Competencies:

• Strong analytical and problem-solving skills.
• High attention to detail and accuracy in laboratory work.
• Good understanding of data integrity and documentation practices.
• Ability to work both independently and as part of a team in a dynamic startup environment.
• Excellent organizational, time management, and communication skills.
• Ability to adapt to evolving processes and regulatory requirements in a greenfield manufacturing setting.