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QA Manager - Product Lifecycle Management

Location
Dublin, County Dublin
Job Type
Permanent
Posted
21 Sep 2022

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Job Description

About the role:

Location: Dublin, Ireland

Job Level: Manager

Optional hybrid work model.

How you will contribute :

  • Management of the Specification program for global strategic Products within the Biologics Operating Unit

  • Owner of global Product Specification Documents (Intermediates, Drug Substances/Products, Plasma and Cell Banks) for internally or externally manufactured commercial products.

  • Managing of global Product Specification Documents (create/revise/obsolesce).

  • Implement changes to Product Specification Documents by assessing/planning/managing of related global Change Controls.

  • Responsible for timely completion of all Change Controls and their related actions.

  • Interface with related Stakeholders (e.g. Product Quality Lead, LIMS and Release).

  • Track any Specification and Change Control activities for the purpose of reporting KPIs.

  • Support and or lead any harmonization and continuous improvement activities

What you bring to Takeda :

  • Scientific degree (BSc, MSc)

  • 4+ years of increasing management responsibility combined with deep knowledge of biopharmaceutical manufacturing

  • Some Experience about Quality pillars (QA, QC, Systems and Compliance, Services and Improvement) including global cGMP regulations (US, EU, Japan, Canada, etc.)

  • Some Experience working with regulatory agencies and/or direct interface experience with regulatory agencies during inspections highly desirable/preferred.

  • Fluent in written and spoken English

  • Critical thinking, analytical, and problem-solving skills

  • Demonstrated sound judgment. Must be confident, resourceful, self-reliant and self-motivated. Prioritizes and manages time effectively to reliably meet timelines

  • Ability to work independently, to organize and structure own work self-sufficiently with limited direction from manager

  • Ability to provide planning and structure for others on the team for tasks around specification management

  • Understanding of local and global regulations

  • Communication skills engaging stakeholders: site, business, network, company, regulators.

  • Courage of conviction and conflict resolution skills.

  • Continuous improvement

  • Personal accountability for results and integrity

  • Strong PC skills and be competent in Word, Excel, PowerPoint and SharePoint

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

Important Considerations:

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:

  • Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.

  • Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.

  • Work in a cold, wet environment.

  • Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.

  • Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

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.

Locations

IRL - Dublin - Baggot Street

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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Details

  • Job Reference: 717421302-2
  • Date Posted: 21 September 2022
  • Recruiter: Takeda Pharmaceutical
    Takeda Pharmaceutical
  • Location: Dublin, County Dublin
  • Salary: On Application
  • Job Type: Permanent