Associate Quality Auditor

The Associate Quality Auditor is responsible for supporting Actylis supplier oversight program in India by conducting onsite audits of approved and prospective suppliers, toll manufacturers, contract manufacturers, warehouses, repackers, and contract testing laboratories.

Conduct onsite audits of India-based suppliers, toll manufacturers, contract manufacturers, repackers, warehouses, and testing laboratories in accordance with the approved audit schedule and Actylis supplier qualification procedures.

Assess supplier quality systems, manufacturing controls, laboratory practices, documentation, traceability, data integrity, change control, deviation management, CAPA, complaint handling, training, and batch or testing record controls.

Support risk-based supplier qualification, requalification, and ongoing supplier monitoring by providing audit outcomes, objective evidence, and follow-up status to Supplier Quality and Global Quality teams.

Support the Global Internal Audit program by assisting with audit preparation, checklist development, document review, audit execution, and follow-up activities across Actylis sites, as assigned.

Participate in internal audits under the direction of the Lead Auditor or Global Quality leadership, helping assess compliance with Actylis procedures, GMP, GDP, ISO standards, and applicable quality system requirements.

Support tracking of internal audit observations, CAPA commitments, due dates, and closure evidence to help ensure timely completion and readiness for customer, certification, or regulatory inspections.

Assess supplier compliance with applicable quality and regulatory expectations, including GMP, GDP, ISO 9001, ISO 22000/FSSC 22000, HACCP, and ISO 17025, based on the nature of the supplier and the products or services provided to Actylis.

Identify and document potential quality and compliance risks, including deficiencies related to documentation practices, data integrity, traceability, cross-contamination controls, laboratory controls, supplier quality systems, and CAPA effectiveness.

Escalate significant audit findings, repeat observations, overdue CAPAs, or supplier compliance concerns through the appropriate Actylis quality governance channels.

Prepare accurate, objective, and timely audit reports that clearly summarize the audit scope, objective evidence reviewed, observations identified, and overall supplier compliance risk.

Review supplier responses to audit observations and assess whether proposed corrective and preventive actions are appropriate, timely, and aligned with the identified root cause and compliance risk.

Track open audit findings, CAPA commitments, and due dates to support timely follow-up and closure.

Collaborate with Procurement, Regulatory Affairs, Quality Control, site Quality teams, and business stakeholders to communicate audit outcomes and support supplier oversight decisions.

Represent Actylis professionally during supplier interactions by applying an objective, respectful, and evidence-based audit approach.

Contribute to continuous improvement of supplier audit tools, checklists, templates, risk assessment practices, and audit tracking processes.

Bachelor s degree in Pharmacy, Chemistry, Microbiology, Chemical Engineering, Food Science, Biotechnology, or a related scientific discipline.

Minimum 2 3 years of hands-on experience conducting or supporting supplier audits, internal audits, laboratory audits, GMP audits, food safety audits, or quality system assessments.

Practical working knowledge of quality system requirements applicable to suppliers, toll manufacturers, contract manufacturers, warehouses, repackers, and testing laboratories.

Formal audit training or certification, such as Internal Auditor, ISO 9001 Auditor, ISO 22000/FSSC 22000 Auditor, ISO 17025 Auditor, Certified Quality Auditor, or equivalent preferred.

Experience supporting supplier qualification, vendor management, external manufacturing oversight, toll manufacturing oversight, or third-party laboratory oversight preferred.

Ability to review procedures, specifications, certificates of analysis, batch records, analytical records, validation documentation, quality agreements, and supplier responses to audit observations.

Strong understanding of audit principles, objective evidence collection, observation classification, documentation practices, data integrity, traceability, and basic risk assessment.

Strong written and verbal communication skills, with the ability to prepare factual, concise, and well-structured audit reports.

Professional, objective, and collaborative approach when interacting with external suppliers and internal stakeholders.

High level of integrity, attention to detail, and commitment to maintaining Actylis quality and compliance standards.