Assistant de service social

GCSMS HANDICAP, D'UN CONTINENT A L'AUTRE; Saint-Laurent-du-Maroni; Sur place; EUR 45 000 - 60 000; Plein temps

Résumé du poste

A leading healthcare organization in Saint-Laurent-du-Maroni is seeking a Quality Systems Specialist to enhance the Quality Management System. Key responsibilities include managing documentation, ensuring compliance with GMP regulations, and providing quality support. Ideal candidates will have a relevant degree, at least three years of experience in the pharmaceutical industry, and a strong understanding of QMS regulations. Continuous improvement and problem-solving skills are essential for this dynamic role.

Qualifications

• At least 3 years of experience in the pharmaceutical industry, preferably in Biologics.
• Understanding and practical application of GMP standards and regulations.
• Working knowledge of QMS regulations and best practices.

Responsabilités

• Manage the documentation management systems with periodic review.
• Provide compliance metrics and quality support to the site.
• Support Regulatory and Compliance Inspections at the site.

Connaissances

Analytical problem-solving skills

Adaptability

Accountability

Aseptic Manufacturing

cGMP Compliance

SAP Master Data experience

Formation

Degree or post-graduate qualification in Science/Pharmacy/Engineering

Description du poste

Job Description

An amazing opportunity has arisen for a Quality Systems Specialist to join our team at our Dunboyne facility. The successful candidate will be responsible for maintenance and continuous improvement of the Quality Management System (QMS). The Quality Systems Specialist will play a crucial role in ensuring compliance with regulatory requirements and driving continuous improvement in our quality systems.

The main area of focus for this role is, but not limited to, documentation management and QMS implementation.

Responsibilities

Bring energy, knowledge, innovation and influence to carry out the following:

• Operate and manage the documentation management systems including periodic review, documentation obsoletion and user access.
• Manage the Documentation Archiving System, including issue and reconciliation of controlled documentation.
• System owner for electronic logbook system (eLogs) including template approval, periodic review and system access.
• Site topic owner for QMS and SOP Lifecycle Management including management of local QMS assessments and implementation reports.
• Generate and provide compliance metrics.
• Provide quality support to the site, including training and guidance on QMS systems.
• Perform QA review of SOPs, risk assessments, change controls, CAPA’s and other documentation related to biologics manufacturing.
• Support Regulatory and Compliance Inspections at the site, as required.
• Support the wider quality team in areas of supplier quality management, quality agreements, new product introduction, deviation management, change control management, master data management and complaint management.
• Ensure the health & well-being of the Quality Management system at the site to ensure timely actions are taken to meet compliance & production needs.
• Comply with our Global and regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
• Drive continuous improvement and participate in initiatives to enhance operational efficiency and resolve issues.

Skills & Qualifications

In order to excel in this role, you will more than likely have:

• Minimum degree or post-graduate qualification (Science/ Pharmacy/ Engineering).
• At least 3 years’ experience in the pharmaceutical industry (preferably experience in Biologics).
• Understanding and practical application of GMP standards and regulations.
• Working knowledge of QMS regulations and best practices.
• Desire to continuously learn, improve and develop.
• Analytical problem-solving skills.
• Experience supporting Documentation Management Systems.
• Experience with Deviation Writing.
• SAP Master Data experience would be an advantage.

Required Skills

Accountability, Accountability, Adaptability, Analytical Thinking, Aseptic Manufacturing, cGMP Compliance, Complaint Management, Data Analysis, Decision Making, Documentation Review, FDA Regulations, GMP Compliance, Interpersonal Relationships, IS Audit, Laboratory Operations, Laboratory Quality Control, Legal Compliance, Manufacturing Compliance, Pharmaceutical Management, Production Operations, Quality Assurance (QA), Quality Inspections, Quality Management, Quality Management System Auditing, Quality Management System Improvement {+ 5 more}