Quality Specialist, Quality Process
PrimeVigilance · Pune · onsite · Posted 42d ago
About a minute. You'll make an account on the way through.
About this role
Leadership and Compliance:
- Provide support and guidance to Ergomed colleagues and functional teams in developing, managing, and implementing Controlled Procedures.
- Ensure GxP activities are conducted in compliance with applicable legislation, guidelines, and standards, including ICH, CIOMS, and ISO.
- May act as the Subject Matter Expert for GxP Quality Operations and Training regulations and the Ergomed Quality Management System, providing input into procedures, policy, and training as required.
- Assist in Driving GxP training activities across the Ergomed group, ensuring employees are adequately trained to meet global GxP requirements and client expectations, with support from the Learning and Development team.
- Assist in ensuring GxP training is efficient and effective and that training activities are tracked to completion
- Partner closely with Learning and Development to drive excellence in training
- Assist in the triage and management of processes controlling access to Ergomed Group Quality Management System.
- Participate in efficiency projects to enhance the use and management of the Ergomed Group
- Ensure access requests to Controlled Systems for employees and clients are reviewed and approved.
- Assist in providing Business Continuity activities across the Ergomed Group.
- Provide support to functional and Quality teams for audits and inspections by supplying reports or procedures from the Ergomed Group Quality Management System.
- Assist in the preparation and analysis of Quality Operations and Training related metrics, providing periodic reports to management.
- Take a role in preparing any required CAPA or Deviation records resulting from issues in the Controlled Document, GxP Training and BCP process.
- Assist in mentoring and leading the Quality Process and Training team helping to develop team members and to build competence, confidence, and subject matter expertise.
- Foster a collaborative, high-performing quality culture across global teams and regions.
- Provide coaching and professional development opportunities to enhance team capability and succession planning. Qualifications
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Sourced from naukri
Skills
About PrimeVigilance
PrimeVigilance
501-1000
employees
2008
18 years old
Guildford
United Kingdom
₹9.7L PA avg
Avg at PrimeVigilance
About
PrimeVigilance, an Ergomed company, was set up by former Pharmacovigilance Regulators in 2008. We have grown to become the leading Pharmacovigilance specialist company, delivering global solutions for both clinical safety and post-marketing pharmacovigilance, as well as medical information from our offices. Having successfully delivered Pharmacovigilance (PV) and Medical Information (MI) services for over 14 years, our experience enables us to offer a comprehensive, top quality, cost-effective, and innovative safety solution. Our flexible approach, tailor-made to work with clients, allows us to deliver the services that meet your clinical and post-marketing needs.
From its operational hubs based in Europe, the USA, and Japan. PrimeVigilance manages a global Pharmacovigilance system with a choice of leading drug safety databases, stretching to more than 100 countries.
• 900+ highly qualified professionals
• Global leader in QPPV services
• 24/7 multilingual call center
• Choice of leading drug safety databases
• Robotic Process Automation (RPA) expertise
• Access to regulatory experts and key opinion leaders
GLOBAL LIFE CYCLE MANAGEMENT SERVICES
• PHARMACOVIGILANCE
• PHARMACOEPIDEMIOLOGY & BENEFIT-RISK MANAGEMENT
• AUDIT & INSPECTION
• QUALITY MANAGEMENT
• REGULATORY SCIENCE
Industries
Employee ratings
9 reviews
Culture
3.4
Career growth
2.9
Work-life
3.7
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