Quality Specialist (QMS, Documentation)

Biopharma Careers; Bengaluru; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Biopharma Careers in Jigani, Bangalore seeks a Quality Assurance Specialist with 7–9 years of experience in the pharmaceutical/chemical/life sciences industries. You will develop, implement, and maintain the quality management system in line with regulatory requirements and drive audits and investigations.

The role collaborates with cross-functional teams to ensure product quality across the lifecycle, analyzes quality metrics, and prepares SOPs, validation protocols, and reports while training

Qualifications

• 7–9 years of experience in quality assurance within pharmaceutical/ chemical/ life sciences or biotechnology industries.
• Strong understanding of regulatory requirements (FDA, EMA, NABL, ANAB) and quality standards (ISO, GMP).
• Excellent analytical, problem-solving and communication skills.
• Ability to work collaboratively in a fast-paced, team-oriented environment.

Responsibilities

• Develop, implement, and maintain the quality management system (QMS) in accordance with regulatory requirements and industry standards.
• Lead and manage quality assurance activities, including audits and investigations.
• Collaborate with cross-functional teams to ensure product quality throughout the product lifecycle.
• Monitor and analyze quality metrics to identify trends and areas for improvement.
• Prepare and review quality documentation, including SOPs, validation protocols, and reports.
• Provide training and guidance to staff on quality assurance practices and regulatory compliance.
• Drive continuous improvement initiatives to enhance product quality and operational efficiency.

Skills

Quality Assurance

Regulatory Compliance

Analytical Skills

Communication Skills

Team Collaboration

Education

Master's degree in Life Sciences

Master's degree in Chemistry

Master's degree in Engineering

Job description

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

Job Title:Quality Assurance – Specialist

Your Role:

• Develop, implement, and maintain the quality management system (QMS) in accordance with regulatory requirements and industry standards.
• Lead and manage quality assurance activities, including audits and investigations.
• Collaborate with cross-functional teams to ensure product quality throughout the product lifecycle.
• Monitor and analyze quality metrics to identify trends and areas for improvement.
• Prepare and review quality documentation, including standard operating procedures (SOPs), validation protocols, and reports.
• Provide training and guidance to staff on quality assurance practices and regulatory compliance.
• Drive continuous improvement initiatives to enhance product quality and operational efficiency.

Who you are:

• Exp: 7 Years to 9 Years
• Location is inJigani, Bangalore
• Education: Master degree in Life Sciences, Chemistry, Engineering, or a related field.
• Minimum of 7 years of experience in quality assurance within the pharmaceutical/ Chemical/life sciences or biotechnology industry.
• Strong understanding of regulatory requirements (e.g., FDA, EMA, NABL, ANAB) and quality standards (e.g., ISO, GMP).
• Excellent analytical, problem-solving, and communication skills.
• Ability to work collaboratively in a fast-paced, team-oriented environment.

What we offer:

We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!