Quality Associate I

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 daily quality oversight during manufacturing, warehousing, and qualification activities, including but not limited to line clearance and AQL sampling.
• Ensure adherence to cGMP, SOPs, and regulatory standards.
• Lead and execute QA review of batch records, logbooks, and related GMP documentation to support timely and accurate product disposition.
• Develop, implement, and maintain site-specific quality procedures (SOPs, work instructions, forms) governing QA support responsibilities
• Ensure proper execution of Good Documentation Practices (GDP)and data integrity in all manufacturing executed records.
• Take active role in preparing the site for regulatory inspection.
• Act as a QA representative during regulatory inspections, internal audits, and customer audits.
• Contribute to the inspection readiness of the site, including periodic walkthroughs and risk-based quality improvements.

Requirements:

Qualifications / Experience

• Bachelor’s degree in a scientific or technical discipline (e.g., Biology, Chemistry, Pharmacy, Engineering).
• 5+ years of experience in pharmaceutical manufacturing, or QA.
• Familiarity with aseptic manufacturing, sterile injectable processes, and cleanroom environments.
• Knowledge of FDA cGMPs, ICH Q8-Q10 guidelines, EU Annex 1, and risk-based qualification approaches.
• Experience supporting regulatory inspections and validation documentation reviews.

Skills / Competencies

• Strong knowledge of 21 CFR part 10, and 211.
• Strong knowledge of aseptic GMP manufacturing and QA shopfloor support.
• Excellent organizational and communication skills with high attention to detail.
• Ability to work collaboratively with operations, and engineering.
• Commitment to data integrity, continuous improvement, and patient safety.