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QA & PV Manager Baltics & Estonia / GDP Responsible Person Estonia

Apply Now Email Me Job ID R0014413 Date posted 11/19/2019 Location: Tallinn, Estonia

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Job Description

Accountabilities

  • Leadership:
    • Lead local processes to hire new /QA/PV personnel
    • Leverage of strong leadership culture in order to develop highly qualified employees
    • Support onboarding, training, and knowledge transfer together with Regional MCO RA/QA/PV within LOC RA/QA/PV providing an upskilling on negotiations and networking
    • Ambassador for Corporate Philosophy and Takeda-ism
    • Act as a communication link between local /QA/PV and MCO RA/QA/PV
  • Quality Assurance
    • Responsible for the implementation of Global Standards and Standard Operating procedures (SOPs) that are aligned with local requirements
    • Develop and maintain GxP related controlled documents in the LOC Quality Management System with the support of MCO EE Quality
    • Ensures that LOC Quality Management System (QMS) is implemented and aligned with the needs of the organization, including contribution for development and review of QMS documents
    • Track and assess if local documents are compliant with local/global GxP requirements and arrange for necessary actions, such as consultation with subject matter experts, MCO RA/QA/PV Head and creation/update of processes and applicable training
    • Support and cooperate with the MCO RA/QA/PV Head in achieving the quality and business objectives
    • Responsible for the implementation in the individual LOC processes
    • Perform self-assessments and responsible to organize audits of the LOC/GxP vendors to monitor compliance with applicable procedures and requirements
    • Manage inspections/audits and ensure audit/inspection readiness
    • Build a quality culture and support the implementation of quality improvement plans
    • Manage LOC quality issues (complaints, recalls, deviations, CAPAs) effectively
    • Prepare LOC Monthly Quality Council report and timely share with MCO RA/QA/PV Head
    • Maintain oversight of contracts and quality agreements on LOC level
    • Good Distribution Practice Responsible Person (GDP RP) for the Estonian Distribution License
    • Responsible for making changes to Manufacturing Licence content in collaboration with the Qualified Person (QP) of the manufacturing site Ensures approval of Material Masters in SAP.
    • Takeda Pharma AS’ 24/7 contact for the State Agency of Medicines in Estonia.
  • Pharmacovigilance (as Drug Safety Officer for LOC Estonia)
    • Maintain current robust, consistent and compliant Pharmacovigilance (PV) processes in Estonia (business continuity plan, service level agreement, DSO mailbox monitoring, managing any safety information)
    • Ensure basic drug safety awareness training of all Takeda employees in the LOC and of all external service providers involved in activities, where potential drug safety information are likely to be reported
    • Facilitate and support local PV audits and inspections and responsible for completion of PV related commitments
    • Keep abreast of local PV legislation and notifies the global organization of any changes and implements as necessary
    • Informs global organization on all local 3rd party agreements (service providers, in- or out-licensing of products) within the LOC
    • Responsible for implementation of local risk minimization activities for relevant products in cooperation RA responsible
    • Monitor Market Research (MR) and/or Patient Support Programs (PSPs) conducted at the LOC to ensure safety information is managed appropriately
    • Ensure compliance to both local and global standards and procedures,
    • Follow appropriate documentation practices
    • Ensures 24/7 coverage for PV related matters in the LOC
  • Medical Information Service as a backup in Estonia:
    • In the absence of Medical Affairs Lead Baltics & Estonia:
      • Provides accurate and non-promotional Medical Information related to licensed and unlicensed products and indications following unsolicited requests from HCPs, pharmacists, and patients in Estonia.

Area covered: Estonia, Latvia, Lithuania

Education, behavioral competencies and skills

  • Essential:
    • Advanced degree in scientific discipline pharmacist
    • Experience and proven track record in quality assurance
    • Pharmacovigilance experience is an advantage
    • Experience of working in a matrix management environment
    • Deep understanding of EU and local laws, regulations and Industry codes related to  GVP and GDP
    • Proven conflict management and independent problem-solving skills
    • Advanced process management skills
    • Drives performance of self and others
    • Highest ethical standards
    • Excellent communication and collaboration skills with external and internal stakeholders
    • Excellent organizational skills
    • Proven experience in successfully managing several projects at the same time
  • Desired:
    • On job experience in a Pharmaceutical company in the last 3 to 5 years
    • Excellent leadership and coaching skills
    • Ability to influence at a high level
  • Other requirements:
    • Travel across LOC as needed, MCO and other EU countries (for training if needed)
    •  Valid and clean driver’s license

Licenses/Certifications:

  • As GDP RP
    • an academic degree of a dispensing chemist acquired in a university, or a corresponding foreign qualification
    • at least one year of professional experience in a company holding an activity license for the wholesale of medicinal products or in a general pharmacy

Locations

Tallinn, Estonia

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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