LOC Quality head
Almaty, Kazakhstan
2 дня назад

Job Description

Roles and Responsibilities

1. Manage GxP-regulated activities in LOC to ensure compliance to Takeda requirements & local regulations, and the supply of quality & compliant products to patients in a timely manner

2. Implement Takeda QMS and ensure ongoing compliance to the quality standards and procedures at the LOC. These include but are not limited to : change control, deviation, CAPA management, training, document management, complaint handling, etc.

  • Ensure all relevant LOC colleagues performing GxP / quality-related tasks are appropriately trained prior to performing activities
  • 3. Implement Supplier Quality Program at the LOC using a lifecycle management approach

  • These would encompass the selection & qualification of new suppliers, ongoing quality performance monitoring and exit of suppliers which provide materials and services with GxP / product quality impact
  • 4. Establish and maintain internal and external Quality Agreements

    5. Ensure new GxP-suppliers / contractors are audited and qualified before use. Lead or participate in quality audits, & support QA due diligence of new business partners

    6. Provide quality oversight of local GMP / GDP activities, e.g. local (re)labelling / (re)packaging, cold chain management, temperature excursion management, method transfers, etc

    7. Perform batch releases & / or duty of care releases, in compliance with the applicable local regulations and local procedures, prior to distribution / sale within country.

  • This includes import testing where required under local regulations. Review PQRs to ensure acceptability to the requirements of the market
  • 8. Establish and lead internal audit / self-assessment program at the LOC, to evaluate compliance with product quality systems & processes in LOC, and to identify improvement opportunities

    9. Lead regulatory inspections at the LOC for GMP / GDP / Product quality related activities, and ensure that regulatory commitments are duly completed on time

    10. Develop and execute Annual Country Quality Plan at the LOC. This will include the following :

  • Establish and maintain the local risk register. Engage the key LOC stakeholders to proactively identify GMP / quality risk areas, and establish appropriate risk mitigations and risk monitoring program at the LOC
  • 11. Ensure local Quality Council / Management Review is conducted on a regular basis.

  • Monitor key performance indicators, evaluates and highlights any significant trends and identifies actions
  • 12. Main point of contact for the investigations and resolution of all product quality issues discovered or originating in the LOC and for interacting with the relevant local stakeholders (such as Regulatory Affairs, Medical, BU) and GMS on such issues

    13. Management of product-related complaints in the LOC, and quality investigations at the LOC. Report suspect counterfeit cases and support GPP investigations.

  • Drive timely implementation of CAPAs where required at the LOC, and verify CAPA effectiveness
  • 14. Initiate Notification to Management / escalation report for notifiable events in accordance with Takeda Global Procedure.

  • Execute local recall / market action once the decision is endorsed by Market Action Committee (MAC), and ensure timely completion of the required actions
  • 15. Lead, or support health authority communications on Product Quality issues impacting the country

    16. Lead the implementation of GxP-enterprise system(s) in the LOC, ensuring that CSV and data integrity requirements are met

    17. Drive and strengthen the Quality Culture at the LOC

    18. Gather local regulatory & quality intelligence. To communicate and raise awareness of upcoming and new regulations within Takeda

    19. Provide quality support for product launches

    20. Perform customer bona fide checks, to ensure the appropriate & valid authorizations and licenses are in-place

    21. Ensure responsibilities and duties of RP / QP are complied with (as applicable under the local regulations)

    22. For LOC Quality Head managing a team :

    Manage the performance and development of the team

    Identify and develop talents for the future. Enhance technical knowledge & capabilities, and develop leadership skills

    Budget planning and resource management

    Education, Behavioural Competencies and Skills

    University degree in Pharmaceutical Science, Pharmaceutical Technology, Microbiology, Chemistry or equivalent

    Minimum of 5-7 years in a QA / QC position in Pharmaceutical industry

    Possesses appropriate quality and technical experience, and RP qualifications (latter as required under local regulations)

    Prior experience managing external GMP / GDP suppliers

    Ability to make sound and effective quality decisions under pressure

    Skilled at leading GMP / GDP audits

    Able to work independently

    Fluent in written and spoken English and Russian

    Core Competencies / Skills

    Strong cGMP knowledge and experience

    Familiarity with local and international GMP / GDP regulations

    Critical Thinking skills

    Adept in leading investigation and problem-solving

    Strong communication and stakeholder management skills

    Ability to influence and work effectively across different functions

    Continuous improvement skilled in using Lean tools

    Leadership Behaviors

    Strategic enterprise thinking, finding innovative ways to serve patients build reputation and trust

    Creating the environment that inspires and enables people

    Focusing on the few priorities and provide superior results

    Elevating capabilities for now and the future

    Full time

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