Quality Systems and Regulatory Compliance Specialist (6 months maternity cover) at Cepheid

POSITION SUMMARY:

Assist in maintaining the quality management system (QMS) for the site to ensure continuation and retention of certification. Performing activities that supports elements if the QMS and support local process owners in ensuring QMS and Regulatory compliance. Report any field actions to the regulatory authority within the stipulated timelines.

ESSENTIAL JOB RESPONSIBILITIES:

• Update SOPs as and when Needed to ensure applicability
• Capture Non-Conformance (NCs) into the eQMS system and ensure continuous trending of NCs and their causes (Act as the region’s NC coordinator)
• Facilitate and co-chair CAPA board meetings
• Conduct internal Audits
• Training associates on QMS tools
• Manage Compliance training for regional associates
• Conduct ERP system quality releases of goods
• Report on the Monthly quality KPIs for the site and region

Drive the on time delivery of quality objectives & report for the site and region in collaboration with process owners

• Support the continued effectiveness of the QMS

MINIMUM REQUIREMENTS:

Education and Experience (in years): 

• At least three years experience in Quality Assurance, in the medical diagnostics I pharmaceutical industry or relevant quality assurance qualification
• Any Life Science Degree, Quality Degree or Operations degree

Knowledge and skills:

•  ISO 13485 (2016)
• Basic Knowledge of Local applicable regulatory requirements
• Excellent writing and Verbal Skills (English required)
• Good computer Skills (i.e., MS Office 365, Windows)

Other:

• High adaptability and flexibility
• Multi-tasking ability
• Pay Attention to detail
• Precision in writing (Good English grammar)
• Collaborative (Work well with other teams)
• Careful and thorough

Key relationships

• Maintain good coordination and team work with management and associates of all functional departments for the Site (Customer Services, Filed Application, Technical Support, Service Coordination’s , Logistics, HR, Medical Affairs, Sales
• Liaise with Associates from other Sites in different countries

TRAINING RESPONSIBILITIES: (REQUIRED)

• Complete all assigned and required training satisfactorily and on time

Physical requirements/abilities: 

• Must have good eyesight
• Will be required to work after hours as needed.