Quality Specialist

Overview

Quality Specialist role supporting GxP compliance, eQMS activities, CAPAs, and client audits and inspections for ProPharma's biotech, med device, and pharmaceutical clients.

What you'll do

• Maintain awareness of, and ensure compliance with, the GxP guidelines and regulations relevant to the services provided.
• Support and facilitate eQMS activities (i.e., Change Control, Deviations, Quality Events (QEs), CAPAs, Effectiveness Checks, etc.).
• Develop, recommend, and monitor Deviations, QEs and CAPAs.
• Review, approve, and communicate root cause and CAPAs to stakeholders.
• Perform effectiveness checks on Deviations and QEs to determine efficacy of CAPAs.
• Participate in GxP change management activities including risk and impact analysis review, change plan review and approval, action plan implementation, and tracking to completion, as applicable.
• Support client audits and regulatory inspections processes (including questionnaires), including coordinating and finalizing agendas, document provision, internal logistics and Subject Matter Expert (SME) availability.
• Coordinate and manage audit CAPA responses, including developing responses to CAPAs with support from relevant internal SMEs.
• Track audit and inspection records in eQMS to closure and ensure audit information is maintained and stored in eQMS.
• Generate and prepare reports to communicate outcomes of quality activities.
• Analyze and investigate Deviations and QEs to identify areas for improvement in the quality system.
• Collect, manage, and analyze data related to CAPAs, Deviations, QEs, and quality KPIs.
• Medical Information specific: retrospectively evaluate telephone skills and case reports to ensure compliance standards are met and maintained.
• Other duties as needed.

What you'll need

• University/bachelor's degree and/or appropriate relevant work experience.
• Minimum 2 years of experience working in a Quality Assurance role.
• Knowledge and experience working with GxP Quality Management Systems.
• Fluent in English speaking and writing.
• Proficient computer skills, including Microsoft Office Suite (Outlook, Word, Excel, PowerPoint).
• Exceptional organization, prioritization, project management and delegation skills; able to multitask.
• Excellent attention to detail and focus on quality.
• Excellent verbal, written, and interpersonal communication skills, with the ability to establish strong professional relationships with quality and internal staff, and with clients.
• Exceptional customer service skills with quality and internal staff, and with clients.
• Ability to build positive collaborations with other departments and be open to change.
• Works in a professional manner with clients, team members and management.
• Flexible and proactive toward changing needs.
• Proactive with the ability to work with minimal supervision.

Nice to have

• Deviation, Quality Event, CAPA, Effectiveness Check handling experience.
• Knowledge and experience working with GxP Quality Management Systems including but not limited to record management, reporting, and data analytics.
• Medical Information QA: experience assessing telephone calls in a call center.

Details

• Location: India.
• Hybrid work arrangement for new hires based within a reasonably short commute of an office, as agreed with the manager.