Site Qualified Person

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Job Description

About the role

Act as the main qualified person for Baxalta Belgium Manufacturing S.A. (Takeda) in accordance with applicable regulations.

How you will contribute

• Act as QP for ensuring that the manufacturing , testing , labeling and packaging are in compliance with GMP and requirements of Marketing Autorization
• Perform on time the batch release certification of raw materials, intermediates and final products, in compliance with EU guidelines and MOH requirements;
• Sign and update the release product registers;
• Handle legal retention samples (sampling, storage, destruction);
• Review and approve Annual Product Quality Review;
• Ensure compliance with different guidelines (Annex 16, Annex 21, …);
• Ensure alignment with upstream QP’s.
• Act as QP for IMP / clinical studies according to EU Annex 13 guidelines.
• Manage the QP Delegate sub-team by defining in alignment with site QA objectives the individual and team objectives, perform mid and end year review as defined by Takeda guidelines.
• Empower individual in their personal development plan, identify the appropriate training session to achieve personal objectives.
• Ensure and support continuous training of team members to achieve their daily activities and duties.
• Act as contact person for CMO oversight, External Quality collaboration, out licensed partners.
• Ensure appropriate quality system is in place, including quality agreements with internal/external partners.
• Manage the quality organization when Takeda Lessines acts as supplier and CMO.
• Be the contact person of the Belgium Authorities (AFMPS).
• Review of change controls and communicate to AFMPS if needed.
• Participate to audits with authorities from various countries.
• Review and approve release, product specifications, documentation,… through the appropriate system, per Annex 16.
• Redact declaration letters and QP statements to MOHs, OMCL and RA submission (new license registration, renewals, changes, clarification etc...).
• Support the implementation of projects for e.g. launches of new products and/or geographies, QC changes methods/ tests in alignment with MOH requirements/ certification, …
• Be the contact person for RA requests related to COA and QP declarations. Track requests and provide them on time to ensure on time submission. Work in collaboration with compliance team.
• Author, revise and/or review release team SOPs as assigned; own batch protocol and batch certificate and ensure adequation with license.
• Perform gembas & take part in the improvement of internal processes.
• Contribute to the quality department’s activities to ensure continuity of activities.
• Training and coaching of delegate QP’s and interns.
• Act as QP in Takeda Global QP meetings.
• Represent Baxalta Belgium Manufacturing S.A. (Takeda) through Baxalta (Takeda) QP network and through VAPI.
  

What you bring to Takeda

Education And Experience Requirements

• Registered Qualified person in Belgium certified by AFMPS (Belgian royal decree of Dec 2006 art 48).
• At least 5 year experience in a similar function.
• Knowledge of quality systems, EU and FDA regulations, cGMP, GDP, Eudralex, Annex 16, Annex 13.
• Fluent in French and English (spoken and written knowledge).
  

Key Skills, Abilities, And Competencies

• Ability to manage priorities.
• Ability to work in a multi-disciplinary team environment.
• Fact-based / Pragmatic / Critical thinking / Rigor / autonomy / proactivity / Stress-resistant.
• Good organizational, planning and communication skills.
• Learning attitude and continuous improvement mindset.
• Knowledge of/experience with plasma derivated product purification, aseptic processes, visual inspection and packaging/labelling.
• Computer skills MS Office.
  

Complexity and Problem Solving

• Ability to perform risk based, timely and quality decisions regarding compliance activities.
• Demonstrate ability to interpret data / information and escalate to management as appropriate.
• Critical deviation review.
• Lot certification decision.
• Ability to influence and resolve conflict.
  

More about us

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Empowering our people to shine

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information, or characteristics, marital or other status. At Takeda, we embrace diversity as a whole.

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Locations

BEL - Lessines

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time