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Project Quality Manager (PQM)- IT/QM Compliance- Basel, Switzerland
Eingestellt von Empiric Solutions
Gesuchte Skills: Client, Support
Projektbeschreibung
NEW CONTRACT OPPORTUNITY: PROJECT QUALITY MANAGER (PQM)- IT/QM COMPLIANCE- PHARMA INDUSTRY- BASEL, SWITZERLAND
Empiric Solutions are currently seeking for an experienced PROJECT QUALITY MANAGER (PQM) for a global and highly sought Pharmaceutical Industry in Basel, Switzerland. This a fantastic 6-12 months contract opportunity with a great competitive salary package.
The following PROJECT QUALITY MANAGER (PQM)will need to have the following skills and experience.
SKILLS AND EXPERIENCE:
- 5-8 years' relevant work experience in IT/QM compliance.
- Excellent English communication skills, both written and oral, additional languages would be a plus.
- Able to manage direct relations with stakeholders and project team members. Should have worked in large programs.
- GxP, 21 CFR Part 11, and SOX knowledge
- SDLC and GAMP knowledge
JOB RESPONSIBILITIES:
- Understand and adhere to the SOPs on Project Management, Change Management, Document Management and Quality Management; and the client Group Computerized System Validation concept with regards to document management.
- Support project managers on the application of the project methodology
- Driving achievements of the Validation/Quality goals by ensuring that the process and standards defined for the project are followed
- Escalating project quality issues to project team & Program PQM
- Along with the project manager, prepare and reply to project-related CSV or audits, assessments or inspections where applicable
- Supporting PM in risk management activities
- Along with the project manager, participate and document project handover to operations
- Change management from quality manager role perspective
- Create/review and approve high level project deliverable (project management and quality management)
- Record project-originated GxP deviations where applicable
- Reviewing and managing test deviations from compliance perspective
- Train and coach the project team, as required, on relevant project procedures, good documentation practice, good testing practice and CSV basics, where applicable
This is a great opportunity to work for a Global Pharmaceutical Industry in Switzerland and immense your self with fresh air and plenty of chocolate.
We are looking forward to receiving your application, indicating your earliest date of entry and your salary. If you need more information about the role, please call Naz for a confidential chat.
Empiric Solutions are currently seeking for an experienced PROJECT QUALITY MANAGER (PQM) for a global and highly sought Pharmaceutical Industry in Basel, Switzerland. This a fantastic 6-12 months contract opportunity with a great competitive salary package.
The following PROJECT QUALITY MANAGER (PQM)will need to have the following skills and experience.
SKILLS AND EXPERIENCE:
- 5-8 years' relevant work experience in IT/QM compliance.
- Excellent English communication skills, both written and oral, additional languages would be a plus.
- Able to manage direct relations with stakeholders and project team members. Should have worked in large programs.
- GxP, 21 CFR Part 11, and SOX knowledge
- SDLC and GAMP knowledge
JOB RESPONSIBILITIES:
- Understand and adhere to the SOPs on Project Management, Change Management, Document Management and Quality Management; and the client Group Computerized System Validation concept with regards to document management.
- Support project managers on the application of the project methodology
- Driving achievements of the Validation/Quality goals by ensuring that the process and standards defined for the project are followed
- Escalating project quality issues to project team & Program PQM
- Along with the project manager, prepare and reply to project-related CSV or audits, assessments or inspections where applicable
- Supporting PM in risk management activities
- Along with the project manager, participate and document project handover to operations
- Change management from quality manager role perspective
- Create/review and approve high level project deliverable (project management and quality management)
- Record project-originated GxP deviations where applicable
- Reviewing and managing test deviations from compliance perspective
- Train and coach the project team, as required, on relevant project procedures, good documentation practice, good testing practice and CSV basics, where applicable
This is a great opportunity to work for a Global Pharmaceutical Industry in Switzerland and immense your self with fresh air and plenty of chocolate.
We are looking forward to receiving your application, indicating your earliest date of entry and your salary. If you need more information about the role, please call Naz for a confidential chat.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Sonstiges