Job Title: Assistant Manager, Global Quality GMP Auditing

Location: Jui Nagar, Navi Mumbai, India

About STADA: STADA is a global healthcare company with more than 130 years of heritage and expertise in delivering high-quality pharmaceutical products. Headquartered in Bad Vilbel, Germany, STADA is committed to improving people's health and quality of life through a broad portfolio of Consumer Healthcare, Generics, and Specialty Pharma products. Operating in more than 100 countries worldwide, we are recognized as a trusted and reliable partner by patients, healthcare professionals, and business partners alike. At STADA, we foster an inclusive and dynamic work workplace that empowers employees to grow, innovate, and develop both professionally and personally.

About the role: Conduct internal GMP, GDP, and Quality System audits across STADA manufacturing sites & affiliates to assess compliance with applicable regulatory requirements, including EU GMP guidelines, and STADA quality standards. The role is responsible for planning, executing, and reporting audits; evaluating audit outcomes; supporting product and site risk assessments; and monitoring the implementation of corrective and preventive actions. In close collaboration with site leadership and global quality functions, the position contributes to inspection readiness programs, quality compliance initiatives, and continuous improvement activities across STADA manufacturing sites & affiliates. It also supports the maintenance of a robust quality management system and promotes a culture of inspection readiness and operational excellence throughout the organization.

Job Responsibilities:

Audit Execution & Compliance • Plan, prepare, conduct, and report GMP/GDP and Quality System audits at STADA manufacturing sites & affiliates to assess compliance with applicable regulatory requirements, including EU GMP guidelines and STADA Quality Standards. • Prepare audit reports in accordance with Global Audit Reporting Templates.



• Evaluate audit outcomes and share relevant audit documentation with Global Quality stakeholders. • Monitor timely implementation and effectiveness of corrective and preventive actions (CAPAs) arising from audit findings. • Maintain audit records, reports, and follow-up activities within designated quality management systems. • Support quality risk assessments related to products, processes, and third-party contractors, where applicable.

Inspection Readiness • Conduct mock audits and readiness assessments to support inspection preparedness across STADA manufacturing sites & affiliates. • Lead and support inspection readiness programs to ensure ongoing compliance with regulatory expectations. Page 1 of 2 • Exchange inspection outcomes, lessons learned, and best practices with Global Quality functions and site management. • Provide guidance on GMP compliance, documentation requirements, and inspection readiness activities.

Quality Risk Management (SQRA & CQRA) • Lead and coordinate SQRA for manufacturing sites and CQRA for STADA affiliates, including risk assessment, CAPA review, and remediation planning. • Monitor SQRA/CQRA action plans and ensure timely closure of identified risks. • Maintain and update SQRA/CQRA questionnaires and assessment tools in line with GMP and regulatory requirements. • Identify and communicate quality risks, recurring deficiencies, and compliance trends to Site, Affiliate, and Global Quality Management. • Prepare and present SQRA/CQRA results, risk assessments, and CAPA status to relevant management and governance forums. • Support Quality Maturity Review Board activities through risk and compliance trend analysis.



• Support sites and affiliates in implementing risk mitigation and continuous improvement actions. • Drive follow-up of SQRA/CQRA outcomes to strengthen compliance, quality culture, and inspection readiness.

Stakeholder Management & Continuous Improvement • Maintain close collaboration with Global Quality functions and Site Leadership Teams across the STADA network. • Support the maintenance and continuous improvement of Global SOPs and quality processes based on audit observations, inspection outcomes, and identified compliance risks. • Contribute to initiatives that strengthen quality culture, compliance awareness, inspection readiness, and continuous improvement across manufacturing sites & affiliates.

Key Competencies Required: • Minimum 5 years of experience in GMP, GDP, or Quality System Auditing within the pharmaceutical industry, preferably in Manufacturing, Quality Assurance, Quality Control, or Compliance functions. • Proven experience in conducting audits of manufacturing sites, third-party contractors, and service providers in accordance with EU GMP Guidelines (Part I and Part II), ICH Q7, and applicable international regulatory requirements. • Strong knowledge of GMP regulations, quality systems, inspection readiness programs, risk management principles, CAPA management, and regulatory inspection expectations. • University degree in Pharmaceutical Sciences, Life Sciences, Chemistry, Biotechnology, or a related scientific discipline. • Proven track record as a GMP/QA Auditor with strong analytical, communication, and stakeholder management skills. • Ability to work effectively with cross-functional and international teams while influencing quality and compliance culture across manufacturing sites. • Excellent written and verbal communication skills in English, with the ability to prepare clear audit reports and present compliance risks to management. • Willingness to travel internationally to support audit execution, inspection readiness activities, and quality improvement programs.

📌 Assistant Manager Global Quality GMP Auditing (Navi Mumbai)
🏢 STADA PHARMA SERVICES INDIA PRIVATE
📍 Navi Mumbai