Quality Assurance

Sipra Labs Ltd; Hyderabad; On-site; INR 900,000 - 1,200,000; Full time

Benefits offered by this job

Competitive compensation

Comprehensive benefits

Professional development

Job summary

Sipra Labs Ltd is seeking a mid-level Quality Assurance specialist to elevate core quality systems and ensure adherence to global standards for regulatory readiness and product integrity. The role emphasizes improving SOPs, CAPAs, and audit processes to sustain excellence.

The position requires onsite work at our Hyderabad facility, with responsibilities spanning vendor qualifications and facilitating FDA/NABL inspections to uphold compliance and product quality.

Qualifications

• 3+ years of direct experience in QA within a regulated industry (life sciences, biotech, medical device).
• GMP/GLP/ISO quality systems knowledge and 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.
• Experience with eQMS software and quality auditing (Nice-to-Haves).
• Certified Quality Auditor (CQA) or equivalent certification (Nice-to-Haves).
• Master's degree in a relevant field (Nice-to-Haves).

Responsibilities

• Manage the complete lifecycle of SOPs, from drafting and review to approval and obsolescence.
• Lead investigations, documentation, and resolution of deviations, CAPAs, and change controls.
• Execute and oversee the internal audit program, including scheduling, conducting audits, reporting findings, and tracking corrective actions.
• Conduct vendor qualification audits and maintain the approved vendor list per quality standards.
• Provide support and documentation during external regulatory inspections (FDA, NABL).

Skills

QA experience

GMP/GLP/ISO knowledge

SOPs management

Onsite work capability

Education

Bachelor's degree in scientific or engineering discipline

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.