Officer Quality Assurance

Avantor

Dehradun

On-site

INR 600,000 - 900,000

Full time

4 days ago
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Job summary

Avantor in Dehradun, India, is seeking a Quality Assurance professional to drive QMS and IPQA activities across manufacturing operations in a highly regulated IVD/Medical Devices environment.

You will review SOPs, batch records, calibration schedules, and ensure CAPA implementation, deviations handling, and regulatory compliance with GMP, ISO 9001, and ISO 13485.

The role requires 2–5 years in QA, with IVD/medical devices exposure, strong communication, and proficiency in MS Office.

Qualifications

  • Must have 2–5 years of QA experience with at least 1 year in IVD/Medical Devices.
  • Knowledge of GMP, GDP, Change Controls, CAPA, Deviations, Non-Conformance Management, and Validation practices.
  • Understanding of ISO 9001, ISO 13485, regulatory requirements, and audit processes.

Responsibilities

  • Execute IPQA activities across fabrication, dispensing, manufacturing, packaging, and dispatch operations to ensure product quality and compliance.
  • Review and maintain SOPs, batch records, calibration schedules, logbooks, and technical documentation.
  • Drive quality improvements by identifying deviations, non-conformances, and process risks, with timely investigations and CAPA implementation.
  • Support QMS activities including handling market complaints, Change Controls, audits, training initiatives, and compliance programs.
  • Collaborate with cross-functional teams to strengthen quality culture and operational excellence.

Skills

GMP Knowledge
GDP Knowledge
CAPA Management
Deviations Handling
Non-Conformance
Process Risk Assessment
Stakeholder Management

Education

Bachelor's/Master's in Life Sciences or related

Tools

MS Office
Document Control Systems

Job description

The Opportunity

The incumbent will play a key role in ensuring product quality, regulatory compliance, and operational excellence by driving Quality Management System (QMS) and In-Process Quality Assurance (IPQA) activities across manufacturing operations. This role offers an opportunity to contribute to a highly regulated IVD/Medical Devices environment, supporting continuous improvement initiatives while ensuring adherence to GMP, ISO 9001, ISO 13485, and quality standards.

What We Are Looking For

Graduate/Post-Graduate in Life Sciences, Biotechnology, Microbiology, Chemistry, Pharmacy, or a related discipline.

2 to 5 years of Quality Assurance experience, including at least 1 year in the IVD or Medical Devices industry.

Sound knowledge of GMP, Good Documentation Practices (GDP), Change Controls, CAPA, Deviations, Non-Conformance Management, and Validation practices.

Knowledge of ISO 9001, ISO 13485, regulatory requirements, and audit processes.

Understanding of ELISA, Clinical Chemistry, Rapid Diagnostics, Hematology, and related manufacturing processes.

Proficiency in MS Office and quality documentation management.

Strong communication, problem-solving, time management, and stakeholder management skills.

How You Will Thrive & Create an Impact

Execute IPQA activities across fabrication, dispensing, manufacturing, packaging, and dispatch operations to ensure consistent product quality and compliance.

Review and maintain SOPs, batch records, calibration schedules, logbooks, and technical documentation.

Drive quality improvements by identifying deviations, non-conformances, and process risks, while ensuring timely investigations and CAPA implementation.

Support QMS activities including handling of market complaints, Change Controls, audits (internal & external), training initiatives, and compliance programs.

Ensure adherence to GMP, GDP, ISO standards, safety requirements, and records management practices.

Collaborate effectively with cross-functional teams to strengthen quality culture and operational excellence.

Contribute to the delivery of safe, compliant, and high-quality products through a proactive, detail-oriented, and continuous improvement mindset.

Disclaimer

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

Avantor is proud to be an equal opportunity employer.

Why Avantor?

Dare to go further in your career. Join our global team of 14,000+ associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science.

The work we do changes people's lives for the better. It brings new patient treatments and therapies to market, giving a cancer survivor the chance to walk his daughter down the aisle. It enables medical devices that help a little boy hear his mom's voice for the first time. Outcomes such as these create unlimited opportunities for you to contribute your talents, learn new skills and grow your career at Avantor.

We are committed to helping you on this journey through our diverse, equitable and inclusive culture which includes learning experiences to support your career growth and success.

At Avantor, dare to go further and see how the impact of your contributions set science in motion to create a better world.

EEO Statement

We are an Equal Employment/Affirmative Action employer and VEVRAA Federal Contractor. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.

If you need a reasonable accommodation for any part of the employment process, please contact us by email at recruiting@avantorsciences.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

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