Investigation Expert

3 days ago

Hyderabad, Telangana, India beBeeInvestigation Full time ₹ 14,44,400 - ₹ 21,44,200

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 1QEM 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 GxP 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 GxP 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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