Quality Compliance Lead

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Job Description

Quality Compliance Lead -

Experience working in sterile / aseptic manufacturing pharmaceutical facilities is essential

Location: Grange Castle

About the role:

The Quality Compliance Specialist is responsible for the coordination of compliance activities with the manufacturing area, and for varying duties as assigned by the Head of Quality Compliance.

Optional hybrid work model.

How you will contribute:

• Becoming embedded in the TILGC P3 Cell Therapy facility as a Compliance Specialist.

• Maintaining oversight of compliance with the ATMP guidelines within the cell therapy facility.

• Ensuring GMP-impacting systems are maintained as per written procedures.

• Becoming a key member of the TILGC audit / inspection teams during external cGMP audits and inspections, e.g., corporate audits and regulatory authority inspections.

• Assisting in implementation of Global Standards and Procedures into the site Quality Management Systems.

• Leading and participating in the P3 self-inspections, maintaining schedule adherence, and tracking actions.

• Actively supporting the development and implementation of continuous improvements to the QMS.

• Participating in Quality Risk Assessments periodic reviews.

• Oversight and preparation of Key Performance Indicators to align with company and global quality objectives.

• Assisting in and facilitating completion of deviation investigations as part of the site Deviation Management System, ensuring effective root cause analysis and appropriate CAPAs.

• Assisting in and coordinating the timely completion of Annual Product Quality Reviews.

• Driving and promoting the corporate values of Takeda-ism within the workplace.

• Maintaining awareness of status of related regulatory / market submissions.

• Assisting in oversight and management of key elements of the Quality Management System (QMS) on site, which includes but not limited to, Inspection Readiness, Quality Council, Complaint coordination and communications, Quality Risk Assessments, and Regulatory Compliance oversight.

• Participating in projects as directed by the Head of Quality Compliance.

• Becoming cross-trained in multiple quality systems.

• Actively fostering, in cooperation with other TILGC staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business.

• Ensuring that Accident Reports / Near Miss Forms are completed in a timely manner after an event.

• On time completion of all assigned trainings, and assessments.

• Other duties as required and directed by the Head of Quality Compliance, or Site Quality Lead.

What you bring to Takeda:

• Bachelor's degree in chemistry, biology or a related scientific discipline.

• Experience working in sterile / aseptic manufacturing pharmaceutical facilities

• A minimum of 7 years working within Quality in the pharmaceutical industry.

• Thorough understanding of sterile / aseptic manufacturing guidelines, the Pharmaceutical Management Systems guidelines, cGMPS, EU / US / JP guidelines.

• Lead Auditor training and experience leading internal audits

• Knowledge of finished product pharmaceuticals/biologics, including analytical chemistry, quality assurance, quality control, process development, and manufacturing operations.

• Excellent verbal and written communication skills.

• Be self-motivated, flexible, organised and a good team player with the ability to prioritise own work based on departmental and site requirements.

• Work directly with other key departments to ensure compliance and productive working relationships.

What Takeda can offer you:

Full Healthcare Cover - includes dependents

Pension Scheme

Attractive Bonus

Subsidised canteen

Parking facilities with electric car charging points

Health & Wellness programs including onsite flu shots and health screenings

Educational Assistance

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 status, or any other characteristic protected by law.

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