Astellas Pharma

The SCM compliance specialist SPD is responsible for the department quality management system. Keeps all documentation up to date, lead the quality process improvements and reports the quality performance. The specialist is organizing the risk management process and all investigations till closureResponsibilities and Accountabilities:• Responsible for maintaining a document management system compliant with GxP requirements.• Performs QA document control functions, including document issuance, reconciliation, distribution, release, and archiving of documents.• Responsible for ensuring Data Integrity within the SPD Group.• Learning Management System LMS key contact, maintain training matrix, owner of curricula within LMS.• Ensures accuracy by reviewing documents for completeness, proper authorization, and impact to other quality systems.• Collaborates with cross-functional departments to ensure timely implementation of document change requests.• Lead Investigations of Non-conformances related to SPD processes and develops effective corrective action plans in collaboration with internal and external stakeholders.• Contribute to Non-Conformances and CaPa outside SPD, impacting SPD group processes.• Assist in providing training to new staff on document management processes and procedures.• Supports audits internal, external to verify that regulatory and quality requirements have been met.• Coordinates the revision, review, and approval and obsoletion of SOPs and other GMP documents. Responsible for ensuring periodic reviews of all related documents and SOPs.• Performs other duties as assigned or special projects as needed.• Organize and lead the Risk management process.• Responsible for periodic quality KPI reporting• Responsible for organizing, preparing, and documenting the periodic quality management reviewLocationsBengaluru, IndiaRequirementsRequired Qualifications:• Education: bachelor’s degree or equivalent• Experience of working in a GxP organization: more than 3 years• Experience with Electronic Document Management Systems.• Excellent communication and interpersonal skills. Excellent judgment, problem resolution & teamwork• Ability to work independently without significant oversight or instruction to achieve results with a high degree of accuracy and attention to detail.• Cross-functional collaboration skills, able to build friendly cooperative relationships including external partiesPreferred Qualifications:• Experience using document management software in a regulated industry.• Proficiency in MS Excel, PowerPoint, and/or Visio to include creation / formatting of charts and data tables.• Experience in an environment subject to regulatory audits/inspections.• Knowledgeable about SAP, Veeva Vault, Track Wise and/or other commonly used tools within GxP environment.• Experience of working in project organizations• Basic knowledge and understanding of supply chain processes.

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