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
Job Types: Full-time, Permanent
Pay: ₹690,194.92 per year
Schedule:
- Day shift
- Morning shift
Work Location: In person