Quality Assurance Associate

StrainX Biotech; India; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Biopatrika is seeking a Quality Assurance professional for Supplier Qualification & External Manufacturing QA. The role demands 5+ years in pharmaceutical QA, with strong GMP and supplier oversight expertise.

You will lead audits, quality agreements, CAPA and change controls, and ensure ALCOA data integrity while aligning with regulatory standards. The ideal candidate collaborates across functions to strengthen quality systems and external manufacturing partnerships.

Qualifications

• B.Pharm or life sciences PG with 5+ years in QA manufacturing.
• Strong knowledge of GMP, vendor qualification, and audits.
• Experience with external manufacturing oversight and change controls.

Responsibilities

• Supplier qualification and lifecycle management of vendors and materials.
• Conduct supplier audits and manage quality agreements.
• Handle material complaints and vendor performance reviews.
• Perform GMP verification and ALCOA compliance.
• Lead due diligence for external manufacturing partners.
• Review deviations, CAPAs, OOS/OOT, and change controls.
• Drive quality risk assessments and inspection readiness.
• Collaborate across functions to ensure robust quality systems.

Skills

GMP Compliance

Supplier Qualification

Audits

Regulatory Compliance

CAPA & Deviation Handling

ALCOA Principles

Education

B.Pharm / Post Graduation in Life Sciences

Job description

We’re Hiring | Quality Assurance – Supplier Qualification & External Manufacturing QA

Role: Quality Assurance – Supplier Qualification & External Manufacturing QA
Experience: 5+ Years
Qualification: B.Pharm / Post Graduation in Life Sciences
Industry: Pharmaceutical Manufacturing

Key Responsibilities

• Supplier qualification and lifecycle management of vendors, service providers, and materials
• Conduct supplier audits and manage quality agreements
• Handle material complaints and vendor performance reviews
• Perform GMP compliance verification and ensure adherence to ALCOA principles
• Lead quality due diligence for external manufacturing and testing partners
• Review deviations, CAPAs, complaints, OOS/OOT investigations, and change controls
• Drive quality risk assessments and inspection readiness activities
• Collaborate cross-functionally to ensure robust quality systems and regulatory compliance

Ideal Candidate

• 5+ years of experience in Manufacturing, Quality Assurance, Development, or Supplier Quality functions
• Strong understanding of GMP, Quality Systems, Vendor Qualification, Audits, and External Manufacturing Oversight
• Experience managing Quality Agreements, Change Controls, and Compliance activities