Spécialiste Qualité QA des opérations PACKAGING - CDI

Job content

New opportunity as QA Ops Packaging Specialist at TAKEDA Lessines, leader bio pharmaceutical.

You have experience in pharmaceutical industry ? in Quality Assurance ? AND in Packaging ?

You are the QA OPS Packaging Specialist we are recruiting for TAKEDA

Read Quickly this joboffer !

RESUME :

The purpose of this job is to act as quality expert for quality/compliance related topics in relation with the Packaging, Visual inspection and Labelling operations.

The function will also support CI and digital initiatives through the Packaging, Visual inspection and Labelling department

RESPONSABILITIES :

Quality Operation within his area of responsibility (Packaging and Labelling):

• Assure the correct deployment of the cGMP, Takeda guidance within the quality operations department

• Represent quality in significant quality-related issues, provide support and expertise. Understanding technical/production complex problems and evaluating potential impact on product quality

• Participate in the definition of the quality requirements for projects related to e.g. process/facility/Equipment modification

• Support any quality decision on the floor in coordination with Manufacturing.

• Review data trending in QA perspective within his frame of responsibility ( for example Visual inspection meeting monitoring)

Quality system within his area of responsibility:

• Act as quality representative in the evaluation, the implementation and the approval of change control

Act as Quality Representative in the evaluation (risk evaluation, mitigations, lots potentially impacted and to be held from release), the investigation (including quality impact) and the approval of deviation Reports Continuous improvement/Digital

• Lead, support and/or participate to continuous improvement initiatives

• Act as a Yellow Belt coach for projects within the department

• Lead and/or support digital initiatives

• Support all global initiatives related to quality related topics for the area of responsibility

• Provide expertise during the revision of Global procedures and guidances

Compliance

• Participate in external inspections.

• Provide support if necessary to the Regulatory team by providing required data for submission files

Votre profil

• Master degree in Sciences (Chemist, Bioingeneer, Bio statiticien, Pharmacist, …)
• Few years experience in GMP environment and manufacturing environment are a plus
• Good IT and digital system knowledge/capability
• French and English (written and spoken – advanced level) – mandatory
• Critical thinking, stress resistant, autonomy,
• Ability to summarise information, technical writing skills,
• Strong communication skills,
• Knowledge in risk management regulation, data analytics skills
• Ability to work in a matrix organization
• Driven by operational excellence and digital solutions
• Focusing on priorities, handle multiple topics simultaneously in a high-volume environment, while meeting deadlines and attention to details
• Ability to work effectively with all levels of management and resolve problems in a timely manner

Offre

We offer you a CDI contract / permanent contract in one of the largest and leading companies in the Bio Pharmaceutical Sector located in Lessines : TAKEDA

Here, the benefits to work for the company Takeda as QA Ops Packing Senior Specialist :

• Atractive salary
• Lunch voucher
• Refund in the travel expenses (go & retrun)
• Insurances
• Etc

Vous correspondez au profil mentionné ci-dessus ? Alors, vous êtes la personne qu’il nous faut !

Contactez-nous sans tarder !