Associate Quality Auditor

Actylis is a global solutions provider with over 75 years of experience, specializing in streamlining the management of critical ingredients and raw materials for our business partners.

We offer both sourcing and manufacturing solutions tailored to meet diverse and evolving needs, ensuring a reliable, agile, and secure supply network. Our commitment to customization allows us to create flexible solutions, whether it’s a unique specification, custom packaging, or tailored logistics strategies.

With deep expertise in quality and regulatory compliance, sourcing and logistics management, analytical services, and R&D support, we reduce complexities and mitigate risks, empowering our partners to focus on growing their business.

In furtherance of that goal, Actylis is seeking new members of the team. This expansion, coupled with a comprehensive benefits package, and opportunities for challenge and growth, make Actylis the ideal place to work and thrive. We hope you’ll consider joining us!

Position Summary 
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.

The role evaluates whether external partners are operating in accordance with applicable Actylis quality requirements, customer expectations, and relevant quality system standards, including GMP, GDP, ISO 9001, ISO 22000/FSSC 22000, HACCP, and ISO 17025, as applicable to the supplier type and product category.

This position is intended for an early-career auditor with 2–3 years of practical auditing experience. The Associate Quality Auditor will execute structured audits, collect objective evidence, write clear audit observations, and support timely CAPA follow-up under the guidance of Supplier Quality and Global Quality leadership.

Key Duties & Responsibilities 

Supplier Audits and Qualification
•    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.

Global Internal Audit Program Support
•    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.

Compliance Oversight
•    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.

Audit Reporting and CAPA Follow-up
•    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.

Cross-functional Collaboration
•    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.

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

Experience
•    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.

Functional/Technical Competencies & Skillsets  

•    Working knowledge of GMP, GDP, ISO 9001, ISO 22000/FSSC 22000, HACCP, ISO 17025, supplier qualification, audit lifecycle management, and CAPA principles.
•    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.

Supervisory Responsibilities: None

Travel Requirements: Regular travel across India is required to conduct onsite audits of suppliers, toll manufacturers, contract manufacturers, warehouses, repackers, and contract testing laboratories. Travel frequency will be driven by the approved supplier audit schedule and business priorities.

Actylis is an Equal Opportunity Employer. Actylis US does not discriminate on the basis of race, religion, color, sex, gender identity or expression, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided based on qualifications, merit, and business need.