Quality Assurance / Regulatory Affairs Manager

Main Functions

The candidate will report directly to the Regulatory Affairs & Quality Assurance (RA/QA). Her/his main tasks will be as follows:

 

Quality Assurance (QA) Assistant

• QMS Documentation – procedures, processes, manuals, templates
• Quality Management System (QMS) monitoring
  • Follow-up the revision history of QMS documents to insure system consistency
  • Support the update of all Standard Operating Procedures (SOP) and Records (REC) of the QMS
  • Ensure that all operative documents are in line with the QMS and properly archived into the system
  • Follow-up changes, complaints, CAPA, deviations managed under QA manager supervision
• Support Auditing services for supplier and sub-supplier compliance with quality, regulatory, standards, and related requirements
• Customers relation support
  • Ensure the timely processing of customer complaints and claims
  • Support the RA/QA manager with any customer request

 

Regulatory Affairs Assistant

• Involved in writing and update of medical device technical files or pharma products regulatory dossiers under the supervision of the Regulatory Affairs (RA) manager
• Helps to maintain certifications in place
• In charge of the regulatory watch performance and report based on standards and norms applicable to the activity of the client

Technical skills

Required

• English (fluent). Italian and/or French will be a plus

Other

• Computer skills (Pack Office)

Personal abilities

Required

• Rigorous, Analytical mind

Other

• Team-player
• Autonomous
• Good Communication skills (verbal and written)

Organization

Lallemand is a privately held Canadian company founded in the late 19th century, which develops, produces, and markets microorganisms for various markets. The administrative offices of the parent company are in Montreal, Canada. Today, Lallemand employs more than 5,000 people working in more than 45 countries on 5 continents.

Thanks to an impressive international network of distributors in the pharmaceutical domain, Lallemand Pharma is able to develop and market medications such as Ismigen®, Immubron®, Respibron®, PIR-05® and Pulmigen®. These immunostimulants, which are used to prevent respiratory infections, contain Polyvalent Mechanical Bacterial Lysate (PMBL®), an active substance produced in Lallemand's GMP-certified factories.

If you specialize in immunology/pneumology clinical research, or if you are a business development specialist in the pharmaceutical industry, we invite you to seek out your next professional challenge at Lallemand Pharma.

Please take note that accommodations will be provided in all parts of the hiring process. Applicants need to make their needs known in advance.