Quality Engineer

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 review and drive to approval of the validation protocols and reports for facility, equipment, laboratory instrument, and utility systems.

• Review and approval of technology/method transfer protocols and reports.
• Review and evaluation of change controls
• Review and approval of deviations and assurance that they define root causes and determine appropriate CAPA.
• Participate in cross-functional teams to support execution of commissioning, installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), and validation protocols.
• Provide quality presence during qualification execution, ensuring data integrity, deviation management, and proper documentation of results.
• Support the timely review and approval of executed qualification documentation and ensure readiness for inspection or submission.
• Drive timely and compliant resolution of deviations, non-conformances, and CAPAs arising during operations and qualification activities.
• Develop, implement, and maintain site-specific quality procedures (SOPs, work instructions, forms) governing validation, change control, deviation, and other SOPs relevant to the responsibilities
• Review and approve site procedures to ensure clarity and compliance with cGMP standards.
• Ensure proper execution of Good Documentation Practices (GDP) in all QA-reviewed documents, including validation records, logbooks, and manufacturing records.
• Act as a QA representative during regulatory inspections, internal audits, and customer audits, with emphasis on operational and qualification-related topics.
• Monitor key quality metrics and drive performance improvements in areas such as deviation reduction, batch record right-first time, and qualification readiness.
• Contribute to the continued inspection readiness of the site, including periodic walkthroughs and risk-based quality improvements.

Requirements:

Qualifications/Experience

• Bachelor’s degree in engineering or technical discipline (e.g., engineering, Biology, Chemistry, Pharmacy).
• 5+ years of experience in pharmaceutical manufacturing QA, including direct involvement in qualification/validation activities.
• Prior experience reviewing or approving qualification protocols and validation reports in GMP environments.
• 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 validation principles and qualification documentation expectations.
• Effective team leader with experience supervising QA staff and coordinating cross-functional support.
• Excellent organizational and communication skills with high attention to detail.
• Ability to work collaboratively with operations, engineering, and validation stakeholders.
• Sound judgment and decision-making under pressure in a dynamic manufacturing environment.
• Commitment to data integrity, continuous improvement, and patient safety.