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Quality Assurance Specialist
Quality Assurance SpecialistMicro Crispr Pvt. Ltd. • Delhi, India
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Quality Assurance Specialist

Quality Assurance Specialist

Micro Crispr Pvt. Ltd. • Delhi, India
30+ days ago
Job description

Step into a role where quality is not a checklist — it is a promise to patients waiting for life-changing therapies.

We are building a next-generation manufacturing ecosystem focused on advanced biologics and viral vector platforms. This role offers the opportunity to work at the intersection of science, compliance, and innovation while shaping a robust Quality Management System aligned with global regulatory expectations.

If precision excites you and documentation feels like architecture rather than paperwork — you will thrive here.

Key Responsibilities

Support the implementation and maintenance of the

Quality Management System (QMS)

in compliance with GMP and regulatory standards.

Manage the lifecycle of controlled documents including

SOPs, specifications, protocols, and batch records.

Perform

document review

to ensure accuracy, completeness, and data integrity.

Participate in handling

deviations, CAPA, change controls, and investigations.

Assist in preparation for internal and external audits.

Ensure effective archival and retrieval of quality documents.

Collaborate with manufacturing, QC, and validation teams to support operational excellence.

Promote a strong culture of compliance and continuous improvement.

Ideal Candidate Profile

1–5 years

of experience in Quality Assurance within

biologics, sterile manufacturing, vaccines, or regulated pharmaceutical environments.

Exposure to

GMP documentation practices

and regulatory expectations.

Working knowledge of QMS processes such as deviations, CAPA, and change control is preferred.

Strong attention to detail with excellent organizational skills.

Ability to work in a fast-paced, highly regulated environment.

Preferred (but not mandatory) :

Exposure to

viral vectors / cell &

gene

therapy

Audit participation

Experience in electronic QMS systems

Do not make viral vector mandatory — you’ll shrink your pipeline.)

Education

M.Pharm / B.Pharm / M.Sc / B.Sc in Life Sciences, Biotechnology, Microbiology, or related discipline.

Why Join Us?

Opportunity to work on cutting-edge therapeutic platforms.

High visibility role with strong learning curve.

Exposure to global quality standards.

A culture that values scientific rigor and bold thinking.

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Quality Assurance Specialist • Delhi, India

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