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Marine Lubrication Engineer - Benelux & France (m/f/x)

6 days ago

Project Technieker

  • Benefits
    • Group insurance
    • Meal vouchers
    • GSM & smartphone
    • Laptop
    • Individual hospital insurance
    • Family hospital insurance
    • Company bicycle
    • Parking
    • Birth
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    • Saint Nicolas
    • Eco Cheque
    • Training
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    • Company meals at reduced prices
    • Additional family benefits

QA/RA Manager

Only 5 days left

Technical Support Specialist

Only 1 day left
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CTRL-F Technical Engineering

QA/RA Manager

Permanent, Full-time
5 days left to apply

QA/RA Manager

Job description

Acts as site responsible for QA and RA matters by:
Ensuring the correct working of the quality management system
Assuring and maintaining the cGMP level
Managing the Quality Assurance and Regulatory Affairs department

Managing the interfaces with customers and health authorities regarding quality and regulatory topics

Position
Drives site cGMP compliance: determine, enforce and maintain the required cGMP level
Takes appropriate actions in cases of non-compliances observed
Ensures that relevant MSOP's, SOP's, WRKI's and other instructions and documents are kept up-to-date and aligned with EU requirements and global policies, where applicable
Keeps Quality Agreements with customers up-to-date
Ensures Manufacturing authorization, GMP licenses, ISO 13485 and other required licenses and certificates regarding medicinal products, medical devices and other products manufactured at Sharp BE are kept up-to-date
Ensures site hygienic and gowning requirements are adequate
Guides and Leads customers audits and audits by health authorities and certifying bodies
Organizes and leads Quality Management Reviews
Sets up, monitors and improves Quality Key Performance Indicators
Manages the internal and external (suppliers) audit schedules
Approves Annual Product Reviews and ensures these are reported timely
Manages timely documentation and responses to customers and authorities (batch records, validation reports, etc.)
Manages quality improvements and CAPA systems
Manages customer complaints
Manages the QA/RA department of Sharp Belgium.
Coaches and evaluates team members
Provides support and pragmatic solutions to the operations department and other departments as appropriate

Profile

Master degree (minimum) preferably in pharmacy or life science.
Completed with relevant training and courses.
Fluent in Dutch and English. French is a pro.
Minimum 5 years of experience within relevant QA/RA positions in the pharmaceutical industry.
Knowledge on Quality systems & cGMP Pro-active
Motivator and leader
Excellent planning and organizing skills
Attention to detail
Thinks in processes and solutions
Result driven and a commercial mindset

Offer

Permanent contract of indefinite duration.
A versatile and challenging job in a strongly growing company, in which you actively participate in the further development of the organization.
Working in a congestion-free environment.
A competitive salary package, complemented by numerous extra benefits including a company car, meal vouchers, hospitalization and disability insurance and group insurance.
A full-time position with sliding working hours and an interesting leave scheme (20 leave days + 11.5 recovery days + 2 sector days).

Questions or interest?

>> lommel@ctrl-f.be

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Requirements
Master (University or Higher Education Long Type) At least 2 years experience