Quality Auditor, India

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 Quality Auditor will be responsible for conducting thorough audits of manufacturing sites, research and development centers, contract organizations, and/or vendors across the India/APAC region to ensure compliance with regulatory standards, internal policies, and Good Manufacturing Practices (GMP). The Quality Auditor will play a key role in supporting risk management, ensuring operational excellence, and maintaining compliance across our global supply chain.

Key Duties & Responsibilities 

Conduct Audits:
•    Plan, schedule, and execute audits of suppliers and/or contractors to ensure compliance with global regulations (GMP, GLP, GDP, ISO, APIC, ICH Q7) as per product compliance requirements.
•    Accompany Customer Audits of Actylis suppliers and ensure a smooth and successful auditing process.
•    Review Customer Audit Agendas to ensure the scope is commensurate with the Supplier’s QMS and the product compliance level required.
•    Perform risk-based audits, focusing on critical areas such as product quality, data integrity, and operational compliance, as required.
•    Plan, schedule, and execute internal audits of Actylis distribution and/or manufacturing sites with regards to Corporate Policies to ensure compliance.

Regulatory Compliance:
•    Ensure adherence to international regulatory standards, including those of the FDA, EMA, WHO, ICH, ISO and/or other relevant regulatory or certification bodies. 
•    Stay updated on changes in pharmaceutical/ISO regulations and industry best practices to ensure continuous compliance.
•    Prepare audit reports and corrective action plans (CAPA) based on findings to mitigate risks and address non-conformities.

Stakeholder Collaboration:
•    Collaborate with cross-functional teams including quality assurance, regulatory affairs, and supply chain to ensure audit outcomes are integrated into continuous improvement strategies.
•    Work with external partners, including contract manufacturing organizations (CMOs) and third-party vendors, to ensure they meet compliance standards.
•    Provide recommendations for process improvements and remediation activities in response to audit findings.

Risk Assessment & Management:
•    Conduct risk assessments to identify high-risk areas within the company’s global operations.
•    Participate in the development of annual audit plans, prioritizing audits based on identified risks and regulatory requirements.

Documentation & Reporting:
•    Document and communicate audit findings clearly and concisely to senior management.
•    Ensure follow-up on the implementation of corrective actions and preventative measures.
•    Maintain thorough and accurate records of all audits, including any compliance violations or quality issues.

Education
•    Bachelor’s degree in Pharmacy, Chemistry, Life Sciences, or a related field. 
•    Certified Internal Auditor (CIA) or Certified Quality Auditor (CQA), highly desired.

Experience
•    Minimum 3 years of experience in auditing within the pharmaceutical industry, with a focus on GMP compliance, regulatory affairs, or quality assurance.
•    Thorough understanding of global regulatory requirements (FDA, EMA, ICH, WHO, ISO 9001:2015, ISO/FSSC 22000, etc.) and good knowledge of industry best practices.
•    Ability to travel up to 60% of the time, as audits are performed across APAC region, primarily India.
•    Experience in a manufacturing setting is considered a strong asset.

Functional/Technical Competencies & Skillsets  

•    Strong knowledge of GMP, GLP, ICH, ISO 9001:2015, ISO/FSSC 22000 and other pharmaceutical and/or nutritional industry standards.
•    Excellent analytical and problem-solving skills with attention to detail.
•    Strong communication skills for clear reporting and ability to influence and negotiate with stakeholders.
•    Familiarity with risk assessment methodologies and audit planning.
•    Proficient in audit tools, systems, and methodologies.
•    Ability to manage multiple audits and meet deadlines in a fast-paced environment.

Behavioral Competencies

•    Customer intimacy: Ability to understand what value your customer wants and how you can deliver it.
•    Simplify & Act with urgency: Critique existing practices / systems for ease of implementation and be responsive.
•    Global mindset: Individual qualities, communication skills, and actionable knowledge that influences multicultural individuals, groups, and organizations.
•    Act as owner: Demonstrate ownership of resources and decisions, be empowered to drive business outcomes.
•     Adapt to change: Comfort of working in ambiguous and rapidly changing work environment, displaying willingness and positive attitude

Supervisory Responsibilities: None

Actylis is an Equal Opportunity Employer. Actylis 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.