QA Associate

As a Quality Assurance professional at our company, you will play a crucial role in ensuring compliance with global regulatory guidelines such as ICH, ICH-GCP, and GMP. Your responsibilities will include managing QMS and maintenance across products/sites and collaborating with various client teams to ensure timely and accurate information. You will monitor changes, ensure QA system compliance, and support audits and inspections by Notified Bodies and regulatory agencies. **Key Responsibilities:** - Ensure adherence to global regulatory guidelines such as ICH, ICH-GCP, GMP - Manage QMS and maintenance across products/sites - Collaborate with client teams to ensure compliance and accuracy - Monitor changes and ensure QA system compliance - Support audits and inspections by Notified Bodies and regulatory agencies **Qualifications & Experience:** - Preferably Postgraduate/PhD degree in Pharmacy/Life Sciences or a related field - 6-8 years of experience in LS QA document control within GMP-regulated environments - At least 2 years of experience in leading RA authoring team(s) - Knowledge of QMS platforms and electronic document management systems is mandatory - Familiarity with eCTD, IDMP, XEVMPD, and GxP compliance - Basic knowledge of industry standards and regulations related to Quality Management Systems - Strong analytical, attention to detail, and problem-solving abilities - Proficiency in MS Office and regulatory work processes - Good knowledge of Global Regulatory submission requirements You will be expected to demonstrate proficiency in Systems & Tools Management, Document Control Systems, Version Control, and QMS. Job stability is a mandatory requirement, and the notice period should be 0 to 15 days only. Please note that the job is located in Bangalore and Hyderabad. Thank you for considering joining our team.,