Position Overview The role of QTC Analyst Senior is primarily responsible for direct action and oversight of the day-to-day operations of ensuring compliance for product release launch activities and post-launch compliance and ensuring compliance as set forth by regulatory agencies and endpoint Quality Management System QMS as well as participate and lead continued growth improvement projects Responsibilities A primary point of contact for resourcing and guidance of product release team Provide QTC review and approval of in-process tasks related to product and or service provision Develop and oversee onboarding and training of Analysts on QTC product release team Act as subject matter expert and point of contact for Software Development Life Cycle process Develop write and revise controlled Validation Deliverables and in continuous improvement efforts and procedures and practices related to product release Provide ad hoc training to Operations staff on compliance procedures associated with product release Responsible to perform the following QTC product release dutiesProvide QTC review and approval of in-process tasks related to product and or service provision Generate perform review and maintain records of Validation Deliverables documentation and ensure compliance to procedures and processes Maintain validation documentation in QMS according with company procedures Provide support to operations staff to develop write and revise controlled Validation Deliverables Act as primary QTC representative and resource to Operations staff with regards to product release Maintain validation documentation in QMS according with company procedures Assist in preparation review and maintenance of reports for identified product events Participate in Root Cause Analysis meetings with the Operational staff and provide input on the identification and documentation of Corrective Actions Preventive Actions for events of discrepancy or failure of released product Assist CAPA team in completion of outstanding CAPA items with the appropriate stakeholders as it relates to product release Support the Governance unit in preparation for External Audits related to product release Perform QMS documentation Quality Control QC reviews on controlled documents such as SOPs Work Instructions and Policies as well as provide feedback to key stakeholders as needed Accountabilities Demonstrate efficient and accurate completion of all responsibilities Experience M S degree and minimum 2 years of related experience OR BS BA degree and minimum 4 years of related experience Certification in Quality Assurance or Regulatory Affairs preferred Minimum 2-4 years of relevant working experience within a regulated environment Substantial working knowledge of FDA regulations 21 CFR Part 11 EU Annex 11 regulations and current industry best practices Knowledge of U S and international regulatory standards and guidelines Relevant experience preferably in the clinical trial industry IRT or CRO experience is highly desired Experience with a QMS and LMS preferred Skills required Strong communication written and verbal organizational and interpersonal skills Strong decision-making skills Project management skills and high level of attention to detail Demonstrated ability to work in a rapid-paced cross-functional team environment Position requires a highly diplomatic and tactful individual with exceptional critical reasoning skills Experience in developing SOPs in for quality assurance and compliance Strong collaboration and development skills Proactive team player enthusiastic with high work ethics Proficient in Microsoft Office applications Outlook Word Excel Visio Microsoft Project Power Point and Adobe Acrobat Professional

📌 Sr. Analyst, Quality Trust & Compliance (systems Validation & Compliance) (Karnataka)
🏢 Important Company of the Sector
📍 Karnataka