Qualified Person (M/F)

Publicado 05-05-2021

Hovione

Lisboa Lisboa (Publicidade / Marketing)


Qualified Person (M/F)

The Qualified Person guarantees cGMP compliance in all activities and systems related to Projects and Products execution. Participates in the implementation of policies, procedures and methods to evaluate and to continuously improve the quality of products and operations throughout the products lifecycle. Collaborates with suppliers and Procurement to assure the quality of their products, materials, components and/or operations.
You will be responsible for:

  • Assure that every batch of medicinal or investigational medicinal product (both human and veterinary use) was manufactured and checked according to EU Good Manufacturing Practices, local legislation in force and International Guidelines (as applicable) and whenever applicable in accordance with the relevant marketing authorization/ product specification file;
  • Ensure that product quality related issues (e.g. recall, quality defects) are notified to the Customers or Health Products Regulatory Authority (as applicable) when product quality issue is of sufficient magnitude to affect the quality/ safety or efficacy of the product;
  • Promote a Quality Culture and Continuous improvement of standards, through the constant oversight of all applicable Quality guidelines and regulations;
  • Manage and coordinate the QP objectives and assure that they are in line with the company strategic plan;
  • Accomplish the local and international legislation applicable to the manufactures of active substances for use in the pharmaceutical industry;
  • Accomplish the local and international legislation applicable to the manufacture of Investigational Medicinal Products and Medicinal Products (both human and veterinary use);
  • Ensure compliance with Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) guidelines and regulations;
  • Assure that the medicinal products (MPs), investigational medicinal products (IMPs) and intermediates for medicinal products manufactured by Hovione are in compliance with the quality requirements of the company (for both human and veterinary use);
  • Coordinate the approval and authorizes the release/certification (as applicable) of the IMPs, MPs and intermediates for medicinal products in order to assure that the GMPs and, whenever applicable, the provisions of the marketing authorisation/ product specification file are applied (for both human and veterinary use);
  • Communicate the quality and regulatory requirements to the different areas of the company;
  • Act as point of contact and communication of quality issues with the Health Authorities and clients;
  • Represent Hovione in meetings with Regulatory Authorities and clients
  • Provide technical support to internal and external customers on product quality related questions;
  • Assure that change control procedures consider regulatory marketing authorization implications, especially for critical changes requiring pre-approval, and inform clients
  • Assure and promote compliance on Health, Safety and Environment in the areas and activities for which is responsible, or in which participates;
  • Act as decision maker in topics related to legal responsibility of the Qualified Person;
  • Manage risk and uncertainty; anticipate and address roadblocks in order to prevent deviations to the goals;
  • Coach project team members to enhance company effectiveness and promote achievement of high standards within the organization;
  • Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others).

We are looking to recruit:

  • University degree in Pharmaceutical Sciences;
  • Title of Specialist in Pharmaceutical Industry by the Ordem dos Farmacêuticos
  • 8 to 12 years? experience in the Pharmaceutical Industry in at least one of the following areas: Production, Quality Control, Quality assurance or Materials Management;
  • In depth knowledge on cGMPs, ICH guidelines, CFR and national and international legislation related to active pharmaceutical ingredients and pharmaceutical products;
  • Good understanding on Company?s business and pharmaceutical industry competitive landscape;
  • Proved leadership and management skills;
  • Ability to identify and resolve complex quality issues
  • Negotiation, communication, and presentation skills;
  • Accuracy and attention to detail;
  • Advanced spoken and written English;
  • Computer literacy and skills as a user for the software implemented in the company and related to the working area.

Hovione is a proud Equal Opportunity Employer
Inclusion and diversity are key to us. At Hovione, that means a work environment where differences are valued, and everyone is treated with fairness and respect. We want all our team members worldwide to feel supported, respected, and have the opportunity to achieve their full potential, regardless of their age, gender, religion, disability, sexual orientation or ethnicity.