Qa Manager – Product Lifecycle Management, Dublin, Takeda Pharmaceutical

Qa Manager – Product Lifecycle Management, Dublin, Takeda Pharmaceutical

Details + Details -

  • Job type: Full time
  • Contract type: Permanent
  • Salary type: Monthly
  • Occupation: Qa manager – product lifecycle management

Location + Location -

  • Country: Ireland
  • Region: Dublin
  • City: Dublin
  • Address: Dublin

Description + Description -

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: Location: Dublin, IrelandJob Level: ManagerOptional hybrid work model. How you will contribute : Management of the Specification program for global strategic Products within the Biologics Operating UnitOwner 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 manufacturingSome 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 EnglishCritical thinking, analytical, and problem-solving skillsDemonstrated sound judgment. Must be confident, resourceful, self-reliant and self-motivated. Prioritizes and manages time effectively to reliably meet timelinesAbility to work independently, to organize and structure own work self-sufficiently with limited direction from managerAbility to provide planning and structure for others on the team for tasks around specification managementUnderstanding of local and global regulationsCommunication skills engaging stakeholders: site, business, network, company, regulators.Courage of conviction and conflict resolution skills.Continuous improvementPersonal accountability for results and integrityStrong PC skills and be competent in Word, Excel, PowerPoint and SharePointWhat Takeda can offer you: Full Healthcare Cover - includes dependentsPension SchemeAttractive BonusSubsidised canteenParking facilities with electric car charging pointsHealth & Wellness programs including onsite flu shots and health screeningsEducational AssistanceImportant 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 RegularTime Type Full time

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