Quality Executive / QA Officer

YONTUS Life Sciences Pvt Ltd.; Guntur District; On-site; INR 900,000 - 1,500,000; Full time

Job summary

YONTUS Life Sciences Pvt Ltd. seeks a qualified Quality Assurance professional to maintain the QMS and SOPs, plan internal audits and risk assessments, and coordinate PT and ILC studies.

The role involves handling CAPA, deviations and change control, plus reviewing validation reports and calibration activities. You will ensure document control, training records, and traceability, while preparing for external assessments and engaging with regulators.

Qualifications

• M.Sc. in Chemistry, Microbiology or Food Science required.
• Certified Internal Auditor — ISO/IEC 17025:2017 (preferred).
• Strong knowledge of GLP, GDP, measurement uncertainty, PT/ILC programs.
• Experience handling regulatory audits (FSSAI, CDSCO, APEDA, EIC).
• Excellent technical writing and documentation discipline.

Responsibilities

• Maintain and continually improve the Quality Management System (QMS) and SOPs.
• Plan and execute internal audits, management reviews and risk assessments.
• Coordinate proficiency testing (PT) and inter-laboratory comparison (ILC) studies.
• Handle customer complaints, deviations, non-conformities, CAPA and change control.
• Review method validation reports, uncertainty budgets and quality control charts.
• Ensure document control, training records and competence assessments are current.
• Coordinate calibration, equipment qualification and reference material traceability.
• Prepare the lab for external assessments and respond to assessor findings.
• Drive a culture of impartiality, confidentiality and data integrity across teams.
• Track quality KPIs and present trends at management review meetings.

Skills

Internal auditing

CAPA & change control

Documentation discipline

Measurement uncertainty

QMS knowledge

Education

M.Sc. in Chemistry / Microbiology / Food Science

Job description

• Maintain and continually improve the Quality Management System (QMS) and SOPs
• Plan and execute internal audits, management reviews and risk assessments
• Coordinate proficiency testing (PT) and inter-laboratory comparison (ILC) studies
• Handle customer complaints, deviations, non-conformities, CAPA and change control
• Review method validation reports, uncertainty budgets and quality control charts
• Ensure document control, training records and competence assessments are current
• Coordinate calibration, equipment qualification and reference material traceability
• Prepare the lab for external assessments and respond to assessor findings
• Drive a culture of impartiality, confidentiality and data integrity across teams
• Track quality KPIs and present trends at management review meetings

Qualifications & Experience

• M.Sc. in Chemistry / Microbiology / Food Science
• Certified Internal Auditor — ISO/IEC 17025:2017 (preferred)
• Strong knowledge of GLP, GDP, uncertainty of measurement, PT/ILC programs
• Experience handling regulatory audits (FSSAI, CDSCO, APEDA, EIC)
• Excellent technical writing and documentation discipline

Core Skills We Look For

ISO/IEC 17025:2017 implementation Internal auditing & gap analysis CAPA, deviation & change control Measurement uncertainty Document control & training matrices

Nice to Have

• Lead Auditor certification (ISO 9001 / ISO 17025)
• Experience with LIMS-based quality workflows
• Exposure to NABL, A2LA or other ILAC-MRA accreditation cycles

What You'll Learn at YONTUS

• End-to-end accreditation lifecycle ownership
• Risk-based thinking across analytical and microbiology operations
• Direct engagement with national and international regulators

YONTUS Life Sciences is an equal-opportunity employer. We welcome applications from women, persons with disabilities and candidates from underrepresented backgrounds.