it compliance specialist (m/f) in loures

posted
job type
temporários
apply now

job details

posted
location
loures, lisboa
job category
Tecnologias de Informação
job type
temporários
reference number
RP-2018-44711
apply now

job description

Randstad Professionals is specialized in Recruitment and Selection of Middle & Top Management. In partnership with Hovione - a Global Company With more than 55 years of experience in Active Pharmaceutical Ingredients ( API ) and Development Intermediate Products - we intend to recruit an 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.

Main responsibilities:

- 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.

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.

skills

Profile:

- 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.