Opis ponude za posao
The IT Compliance Specialist will be responsible for the ownership of 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.
Main responsibilities:
- 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.
Profile:
- 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)
We offer:
- 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.
