Quality Assurance

Goodfit; Hyderabad; On-site; INR 900,000 - 1,200,000; Full time

Job summary

Goodfit seeks a mid-level Quality Assurance specialist to elevate product quality and ensure compliance with global standards, preparing for regulatory outcomes.

You will directly manage core QA systems and contribute to product integrity through audits, SOP management, and regulatory readiness, onsite at our facility.

Qualifications

• 3+ years of QA experience in a regulated industry (life sciences, biotech, medical device).
• Demonstrated expertise in GMP/GLP/ISO quality systems and their practical application.
• Proven track record in managing SOPs, deviations, CAPAs, and change controls from initiation to closure.
• Familiarity with regulatory inspection processes, particularly FDA and NABL guidelines.
• Bachelor's degree in a scientific or engineering discipline.
• Ability to work onsite at our facility.

Responsibilities

• Manage the complete lifecycle of SOPs from drafting to obsolescence.
• Lead investigations, documentation, and resolution for deviations, CAPAs, and change controls.
• Execute and oversee the internal audit program from scheduling to closure of findings.
• Conduct vendor qualification audits and maintain the approved vendor list.
• Provide documentation and support during external regulatory inspections (FDA, NABL).

Skills

GMP/GLP/ISO

SOP management

CAPAs

Change controls

Vendor audits

Audits

Education

Bachelor's degree in Science/Engineering

Tools

eQMS

Job description

Elevate product quality and compliance in a critical mid-level role. As a Quality Assurance specialist, you will directly manage and enhance our core quality systems, ensuring adherence to global standards and preparing us for successful regulatory outcomes. Your expertise will be vital in maintaining our reputation for excellence and directly contributing to product integrity.

Responsibilities

• Manage the complete lifecycle of Standard Operating Procedures (SOPs), from drafting and review to approval and obsolescence.

• Lead the investigation, documentation, and resolution processes for deviations, Corrective and Preventive Actions (CAPAs), and change controls.

• Execute and oversee the internal audit program, including scheduling, conducting audits, reporting findings, and tracking corrective actions.

• Conduct thorough vendor qualification audits and maintain the approved vendor list in accordance with quality standards.

• Provide critical support and documentation during external regulatory inspections (FDA, NABL).

Requirements

• 3+ years of direct experience in Quality Assurance within a regulated industry (e.g., life sciences, biotech, medical device).

• Demonstrated expertise in GMP/GLP/ISO quality systems and their practical application.

• Proven track record in managing SOPs, deviations, CAPAs, and change controls from initiation to closure.

• Familiarity with regulatory inspection processes, particularly FDA and NABL guidelines.

• Bachelor's degree in a scientific or engineering discipline.

• Ability to work effectively onsite at our facility.

Nice-to-Haves

• Experience with electronic Quality Management Systems (eQMS).

• Certified Quality Auditor (CQA) or similar professional certification.

• Master's degree in a relevant field.

What We Offer

• The autonomy to shape and improve critical quality assurance processes.

• Direct influence on product integrity and regulatory compliance.

• A culture that prioritizes precision, quality, and continuous improvement.

• Competitive compensation package and comprehensive benefits.

• Opportunities for professional development and training in advanced QA methodologies.