qa equipment and data integrity partner

To strengthen our QA Systems & Continuous Improvement Team, based in Braine, we

are looking for a talented individual to fill the position of: QA Equipment and Data Integrity

Partner.

General QA Role:

• Promote Quality and Operational Excellence and cultivate “Quality Culture”,

“Compliance Awareness”, “Continuous Improvement Attitude” & “Accountability Culture” across the teams

• Drive Quality Leadership on Quality & Compliance Strategy and interact with other

functional areas to effectively communicate system & process requirements

• Maintaining and continuously improving the Quality Management System and related

processes

• Ensuring continued compliance of the QMS to applicable regulations and guidelines,

The company’s Corporate Policies & Procedures, objectives, plans and projects

Equipment and Data Integrity Partner:

• The Equipment and Data Integrity Partner will be responsible for the administration of the BTO Manufacturing department’s computerized systems and compliance with regulatory requirements

• She/he works closely with the manufacturing teams who own the systems. He/she ensures the link between the users’ needs concerning the day-to-day use of the systems and the system administration and requirements

Main Tasks are:

• Prepare and execute, in partnership with colleagues, the annual program of periodic review of Braine Manufacturing’s computerized equipment

• Data Integrity Risk Assessment

• Reconciliation of accesses

• Participates in new equipment projects in collaboration with the Business Project Manager, the Qualification / Validation, Metrology / Maintenance and IT teams

• Coordinates the Data Integrity Risk Assessment (DIRA)

• Participates in the resolution of identified GAPs

• Define audit trail review strategy

• Ensures the security of raw data, recipes and parameters by proposing adequate backup and security

• Data flow Diagram

• Owner of equipment administration procedures

• Creates the administration document, definition of security levels and privilege

• Access management, process definition

• Maintains the list of equipment, and associated procedure

• Incident management: ensures the management of incidents concerning the software’s system such as data backup, system access problems, etc.

• Shop floor to perform spot-checks on systems, audit trail,...

• Participation on projects: Digitalization Partner

As a QA Equipment and Data Integrity

Partner, you’ll need the following education, experience and skills:

• Master Degree

• High affinity and resourceful with IT systems

• Experience in a regulated pharmaceutical environment or other life science or health related field is preferred

• Experience with Quality Management Systems and Auditing is an asset

• Fluent in French, very good level in English are required

• Affinity for Quality & Compliance and worldwide regulations pertaining to cGMP regulations pertaining to Pharmaceuticals & Medical Devices

• Capability to work with minimal supervision in order for instance to resolve conflict situations with supplier

• Ability to balance multiple priorities

• Fact based decision maker with accountability

• Team player with good interpersonal relationship and communication skills

• Good oral and written communication skills

• Capable of independently identifying problem situations and initiating problem solving

For the position of QA Equipment and Data Integrity Partner , we offer an attractive salary with extra-legal advantages:

• Group insurance

• Hospitalisation insurance

• Meal vouchers of 7 euros gross per working day

• Reimbursement km or company car

• Monthly allowance (80 euros net per month)

• A 13th month

• Training

• Etc.

A rate as a freelancer is also possible.