Quality Associate, Quality Processes – GCP Training Coordinator

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

📋 Description

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

• Support GxP activities to guarantee compliance with relevant legislation, guidelines, and standards.

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

• Facilitate GxP training initiatives throughout the Ergomed group.

• Help ensure that training is effective, efficient, and monitored until completion.

• Collaborate with Learning and Development to help create impactful training programs.

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

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

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

• Assist with Business Continuity initiatives across the Ergomed Group.

• Support audits and inspections by providing necessary reports or procedures.

• Prepare and evaluate Quality Operations and Training metrics along with periodic management reports.

• Help with CAPA or Deviation records that arise from process-related issues.

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

• Provide coaching and support for professional development and succession planning within the team.

⛳️ Requirements

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

• A background in Nursing, Pharmacy, or a BS/Master’s degree in a scientific discipline, or equivalent experience.

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

• Proven experience or capability related to GxP Quality Operations and Training.

• Ability to support GxP training activities and ensure completion tracking.

• Capability to assist with processes related to Quality Management System access.

• Proficiency in supporting business continuity, audits, and inspections.

• Skill in preparing and analyzing quality and training metrics.

• Competence in preparing CAPA or Deviation records.

• Ability to foster a culture of quality, mentor, and assist in professional development.

🏝️ Benefits

• Remote work is allowed.

• Emphasis on work-life balance.

• Collaborative environment with an international team.

• Opportunities for career growth.

• Early ownership and chances for professional development.

• Access to coaching and professional development initiatives.