Investigation expert

1 week ago

Hyderabad, Telangana, India BeBeeInvestigation Full time

About this role The Investigation and Deviation Expert will work collaboratively with process experts and multifunctional operations teams in the Biologics and/or large molecules platform sites. Key Responsibilities: Manage deviations in 1 QEM system for responsible sites using quality management framework. Conduct root cause analysis according to established procedures and site practices. Coordinate with site SPOC and other stakeholders from Production unit, Quality Assurance, Engineering team, and site leadership team. Ensure all stakeholders are informed about investigation progress, manage necessary communications, and adhere to timelines. Participate and facilitate deviation and RCI review meetings, capturing key information and translating it into actionable documentation. Track and report on metrics related to change control documentation, including timeliness, compliance, and quality. Develop, revise, and maintain high-quality documentation related to Deviation management processes, ensuring alignment with regulatory standards. Support quality management system (QMS) actions such as Change Controls, CAPA, effectiveness checks (EC), risk assessments, and OOXs management. Provide technical and scientific expertise to address process-specific matters, ensuring compliance with regulatory requirements and functional standards. Ensure overall inspection readiness for area of responsibility. Support creation and review of Gx P documents, including SOPs, working procedures, and trend reports, while ensuring compliance with internal quality standards and regulatory requirements. Support Health Authority (HA) audits by ensuring compliance with Gx P environment and handling procedural requirements. Support implementation and adherence to instructions and requirements for safe work, environmental protection, and property protection. Comply with internal functional requirements such as KPI reporting, ticket management tools, and other internal procedures and processes. Complete tasks determined during annual objectives setting process and by KPIs, as applicable. Assist team with any ad hoc activities or requests to meet business requirements. About you We are looking for an expert who can lead investigations and deviations with a focus on delivering high-quality results. To be successful, you should have experience in managing investigations and deviations in a regulated environment. You should also have strong analytical and problem-solving skills, as well as excellent communication and collaboration skills. What we offer We offer a competitive compensation package, including benefits, bonuses, and opportunities for professional growth and development. Our company values diversity, equity, and inclusion, and we strive to create a work environment that is welcoming and inclusive for everyone. How to apply If you are a motivated and experienced professional who is passionate about delivering high-quality results, please submit your application through our online portal. We look forward to hearing from you

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