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)
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.
- Ensure IT complies with applicable policies and procedures, training requirements, and applicable regulatory requirements;
- Interpret and communicate systems compliance regulations within the IT function, leveraging Industry learnings, guidance (GAMP), and peer benchmarks;
- Plan, facilitate the preparation/ coordination, and follow-up on audit/inspection findings and lessons learned;
- Facilitation of GMP policies, narratives, and control self-assessment documentation;
- Create and maintain IT compliance documentation and knowledge repository;
- Develop recommendations to improve the IT internal control environment;
- 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.
- Candidate should typically have 5 or more years of experience in an IT, QA or Compliance role with a strong understanding of quality systems compliance;
- Degree in Computer Science or related technical discipline;
- Knowledge with Quality Systems
- Experience in GxP environments is a differentiator;
- Significant experience managing relationships with inspectors and auditors;
- 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;
- Keen attention to detail;
- Excellent Level of English (Written and Spoken)
- 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.