Philip Morris - Quality Compliance Specialist
Support the implementation, maintenance, and continuous improvement of Quality Assurance (QA) program for ISO 17025 to demonstrate to Management that the laboratory activities, facilities, equipment/instrumentation, personnel, methods, procedures, records and systems are under control through QA verification/review, audit and/or inspection. In addition, support Quality Compliance Team relating to GLP & GCLP activities.
We're looking for a:
Quality Compliance Specialist
ISO 17025 Quality Implementation:
- Perform internal audits in accordance to relevant guidelines, including PMI expectations.
- Actively contribute to the entire accreditation process, including the preparation phase, activities during the inspection, and any necessary follow-up.
- Assist in internal and regulatory audits/inspections readiness, in preparation, during the conduct and at the conclusion of the audit by ensuring all ISO 17025 related activities are under control at all time.
- Support the execution of governance for Reduced Risk Products (RRP) and Conventional Cigarettes (CC) for PMI, ensuring adherence with the QMS according to internal and external standards.
- Perform QA review of new and existing controlled-documents for completeness, accuracy, data integrity and maintenance in compliance with ISO 17025 such as standard operating procedures (SOPs), work instruction and forms/templates, validation documentation.
- Contribute to the maintenance, testing, and improvement of Systems related to main accountabilities.
Quality Compliance Team support:
- Support document and record management activities.
- Support lab change management activities.
- Support NC & CAPA management activities.
- Provide training on systems and processes owned by Quality Compliance.
- University in Life science or any relevant field or equivalent skills through demonstrated experience.
Work experience :
- 1-3 years' experience in quality organization, preferably within a GxP environment
- Proven knowledge of Quality Management Systems and related external standards (ISO, GxP) and experience in maintenance of quality management systems and continuous improvement.
- Proven auditing experience in ISO 17025, GLP or in the area of pharmaceutical or life science.
- Experience in life science, in an R&D function preferred.
Others ? function specifics :
- Excellent verbal and written communication skills, with emphasis on technical writing.
- Good planning and organizational skills.
- Experience in project management in a cross-functional and international environment is preferable.
- Able to deal with ambiguity, autonomous and highly action oriented
- Fluent in English and French languages.