Hovione is an international company with over 55 years’ experience in the development and compliant manufacture of Active Pharmaceutical Ingredients and Drug Product Intermediates. With four FDA inspected sites in Portugal, the U.S., Ireland and China, Hovione offers integrated API, particle design, formulation development and GMP manufacturing. In the inhalation area, Hovione is the only independent company offering such a broad range of services.
To reinforce our team we are looking to fill the following position at our Lumiar site:
IT Compliance Specialist (M/F)
The ITCompliance Specialist will be responsible to owning all IT compliance processes by partnering with peers in IT, Quality, and
external Inspection/Audit teams to ensure our processes and solutions comply with existing and future regulations by supporting a risk driven approach to make valuable recommendations on standardization of processes and controls, and influence changes and decisions.
- Responsible for ensuring that Information Technology’s systems are developed and maintained in compliance with GxP regulations, and according to industry best practice;
- Provide senior-level consultation and direction to functional areas on IT Compliance for policy, process, and procedure;
- Identify, propose, initiate, and lead significant improvement initiatives related to Compliance policy, process, and procedure;
- Provide cross-functional leadership with Compliance Consultants & Managers;
- Ensure effective coordination with the Quality Assurance organization; manage relationships with Validation resources and participate in compliance policy-setting bodies on behalf of IT;
- Prepare organization for audits/inspections; manage CAPA and audits for organization, effectively minimizing risk.
- Degree in Computer Science or related technical discipline.
- 5 or more years of experience in IT, QA or Compliance role with a strong understanding of quality systems compliance;
- Extensive experience in GxP environments;
- Extensive knowledge with Quality Systems;
- Significant experience managing relationships with inspectors and auditors;
- Knowledge about current industry technology, systems, trends and changes in the business environment and operations and incorporate them into our processes when beneficial;
- Excellent Level of English (Written and Spoken);
- Proven analytical and problem-solving abilities;
- Ability to effectively prioritize and execute tasks in a high-pressure environment;
- Good written, oral, and interpersonal communication skills;
- Ability to present ideas in business-friendly and user-friendly language;
- Highly self motivated and directed;
- Keen attention to detail.
- Full time opportunity;
- Remuneration and social benefits adjusted to the job function and matching the experience;
- Excellent work environment, with a strong focus on quality.