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Quality Assurance Specialist
Quality Assurance SpecialistMicro Crispr Pvt. Ltd. • Vapi, GUJARAT, India
Quality Assurance Specialist

Quality Assurance Specialist

Micro Crispr Pvt. Ltd. • Vapi, GUJARAT, India
5 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.
  • Create a job alert for this search

    Quality Assurance Specialist • Vapi, GUJARAT, India

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