Primary Activities and Responsibilities include but are not limited to:
The following core responsibilities are generally applicable to the In-Market Quality, or Quality Responsible Person (QRP) role in the countries (Thailand): Ensure regulations pertaining to Quality and Compliance for importation, distribution and wholesaling of the products on the markets (e.g. Good Distribution Practice) are fulfilled (where applicable as per the country distribution model) Where applicable, ensure adherence to the Companys Quality Management System (QMS) and provide feedback to the Companys QMS topic Manual Chapter owners Health Authority (HA) interactions and notifications regarding Quality issues Information and interaction with local business and regional Quality Management Ensure Quality perspective is brought into local business initiatives with Quality impact Local coordination and execution of recalls Product quality complaint related such as CAPA follow... up, HA notification etc. Primary contact for the countries for the Companys Quality function Primary contact for the countries for HA issues pertaining to Quality issues Local batch release for distribution
Quality Responsible Person Authority
The responsibilities above also include authority to issue instructions, act and take decisions to fulfill HA requirements and to safeguard patient health.
In case of serious product quality related issues (e.g. serious complaints, deviations impacting quality or a potential market action) the QRP has the authority to proceed with necessary actions (e.g. HA notification, administrative hold, recall) as per required urgency and will work in close cooperation with key functions in the Companys Quality organization (i.e. Qualified Persons).
Key competencies, skills & experience required Bachelors degree in Pharmacist. The position will be one of the Registered Pharmacist. Must be Locally registered pharmacist with a valid registered pharmacist license Must have expertise and broad experience in Quality area (GMP and GDP). Experience in Supply Chain or Regulatory Affairs is advantage Must have excellent problem-solving skills, based on science, facts, data and understanding of the regulatory requirements in complex and evolving environments; must be able to apply sound risk management; Must have the ability to influence management of complex operations, protecting company image and reputation with patients, medical stakeholders and regulatory agencies. Must have strong demonstrated interpersonal, communication, negotiation, persuasion and leadership skills in dealing with a broad variety of cultures on non-routine matters in stressful situations. Able to handle organizational complexity and ambiguity Must have exemplary people/team collaboration experience, including speaking candidly, and motivating teams.
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