Qualification & Validation Team Member – Biopharmaceuticals
Location: Bangalore, Karnataka, India
Experience Required: Expert-level, 5–8 years in Biopharmaceuticals
Division: Essential Functions
Company: Syngene International Limited
About Syngene:
Syngene International Ltd. (www.syngeneintl.com) is a leading innovation-driven contract research, development, and manufacturing organization (CRDMO), providing integrated scientific services from early discovery to commercial supply. With a global presence and state-of-the-art facilities, Syngene partners with top pharmaceutical, biotechnology, and life sciences companies to accelerate drug development, maintain IP security, and deliver high-quality solutions.
Role Overview:
Syngene is seeking an experienced Qualification & Validation Team Member to join its Corporate Quality Assurance (CQA) function in Bangalore. The role focuses on ensuring regulatory-compliant qualification and validation of biopharmaceutical equipment and processes, supporting operational excellence, and implementing continuous improvement initiatives. This position offers exposure to emerging technologies and advanced quality systems while fostering a collaborative environment to address complex technical challenges.
Key Responsibilities:
Monitor and maintain the health of qualification and validation processes for drug substances and drug products.
Review, approve, and support documentation related to equipment qualification, requalification, and QMS activities in compliance with approved procedures and regulatory standards.
Identify, coach, and mentor team members to support continuous improvement and operational excellence.
Ensure compliance with internal, client, and regulatory audit observations; provide appropriate responses and corrective actions.
Drive operational excellence projects and implement best practices in validation processes.
Support implementation of newer technologies and methodologies in line with global regulatory expectations.
Required Qualifications & Experience:
M.Sc or B.E. in Life Sciences, Biopharmaceuticals, Biotechnology, or equivalent.
Expert-level experience in biopharmaceutical drug substances and drug products industry.
Hands-on experience in equipment qualification including HVAC systems, LAFs, Biosafety Cabinets, autoclaves, and other critical manufacturing equipment.
Strong understanding of temperature mapping and environmental monitoring.
Experience in Green Belt Six Sigma projects or similar process improvement initiatives.
Key Skills & Competencies:
Expertise in qualification and validation of biopharmaceutical equipment and processes.
Strong scientific reasoning to troubleshoot complex technical problems and implement solutions.
Collaborative mindset with effective teamwork and communication skills.
Ability to maintain high standards of quality, compliance, and regulatory adherence.
Why Join Syngene:
Work in a global, GLP/GMP-compliant environment with exposure to biopharmaceutical manufacturing and quality systems.
Opportunity to contribute to innovative CQA initiatives and process improvement projects.
Collaborate with cross-functional teams to enhance operational excellence and implement advanced validation strategies.
Equal Opportunity Employer:
Syngene provides equal employment opportunities and reasonable accommodations for individuals with disabilities, fostering a diverse and inclusive workplace.
Learn More: Visit Syngene International for insights into services, innovation, and career opportunities.
Apply Now to join Syngene as a Qualification & Validation Team Member and advance your career in biopharmaceutical quality assurance and validation.
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