Quality Associate, Quality Processes

This is a fully remote position, open to applicants in India.

📋 Description

• Assist colleagues and functional teams in the creation, management, and implementation of Controlled Procedures.

• Support GxP activities to ensure adherence to relevant legislation, guidelines, and standards, including ICH, CIOMS, and ISO.

• Offer guidance on procedures and requirements pertaining to GxP Quality Operations and Training.

• Facilitate GxP training initiatives across the Ergomed group.

• Monitor training activities until completion.

• Collaborate with Learning and Development to design effective training programs.

• Aid in the triage and management of access to the Ergomed Group Quality Management System.

• Engage in efficiency projects aimed at improving the use and management of the Quality Management System.

• Oversee access requests to Controlled Systems for employees and clients.

• Support Business Continuity activities throughout the Ergomed Group.

• Assist functional and Quality teams during audits and inspections by providing reports or procedures.

• Compile and evaluate Quality Operations and Training metrics and deliver periodic reports to management.

• Help prepare CAPA or Deviation records that arise from issues in Controlled Document, GxP Training, or BCP processes.

• Cultivate a collaborative, high-performing quality culture among global teams and regions.

• Provide coaching and professional development opportunities to enhance team capabilities and succession planning.

⛳️ Requirements

• A university degree in Biomedical Sciences, Natural Sciences, or Health Sciences is required.

• A Nursing, Pharmacy, or BS/Master’s degree in a scientific field, or relevant experience.

• Familiarity with applicable GxP legislation, guidelines, and standards, including ICH, CIOMS, and ISO.

• Ability to support Controlled Procedures and Quality Management System processes.

• Capability to aid GxP training activities and track their completion.

• Competence in assisting with Business Continuity activities, audits, and inspections.

• Skill in preparing and analyzing quality metrics and periodic management reports.

• Proficiency in preparing CAPA or Deviation records.

• Ability to provide coaching and support for professional development.

🏝️ Benefits

• Opportunity for remote work.

• Emphasis on work-life balance.

• Access to a collaborative international team.

• Potential for career growth.

• Opportunities for professional development.

• Coaching and professional development support available.