Investigation & Client Quality Specialist

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

This is an outstanding chance to contribute to our world-class healthcare team and drive outstanding quality standards!

Job Responsibilities

• Manage deviations and investigations, including complaints and non-conformities in raw materials and GMP materials, ensuring timely completion.
• Coordinate the CAPA system derived from quality investigations.
• Prepare periodic quality trend reports for Management and Corporate dissemination.
• Support and actively participate in Operational Excellence initiatives and projects.
• Collaborate with various company functions to define causes and implement corrective action plans within specified timelines.
• Verify the efficiency of corrective actions over time.
• Coordinate and participate in technical and managerial meetings with clients.
• Participate in client visits, quality inspections, and internal regulatory inspections.
• Generate reports related to quality events.
• Achieve quality objectives in areas such as RFT, Deviation Rate, Past due, and Ontime closure.
• Contribute to Business/customer happiness objectives.
• Review and draft Quality System SOPs in collaboration with Compliance colleagues.
• Deliver timely client support via TLC and email.
• Draft FMEAs and manage controlled company documentation.
• Train personnel involved in quality PDS/DPS activities.
• Draft QATs, negotiate with Clients, site QPs, and legal, following the responsible person’s scheduling.
• Act as SME and QO reference for assigned projects, ensuring successful project completion and GMP batch disposition.
• Support Readiness and BU processes.

Requirements

• Proven experience in quality management within a healthcare setting.
• Strong ability to manage investigations and corrective actions.
• Excellent communication and collaboration skills.
• Ability to successfully implement quality initiatives and meet rigorous standards.
• Ambitious and determined to support world-class healthcare solutions.

Join us and make a difference in the healthcare industry. Apply today and become a part of an ambitious team dedicated to achieving flawless quality in everything we do!