Main responsibilities and activities
In the Quality Compliance Department we are looking for a brilliant profile reporting to the Quality Compliance Manager with the following responsibilities and activities:
Supports the management of Regulatory audits, self-inspections and customer audits.
Support the inspection readiness of the site performing the assigned duties, as shop-floor rounds, capa plan prepararion and CAPA follow up.
Support the manager in issuing and reviewing the site GMP and QMS documents, as SMF, SOPs, QC documents.
Carry out specific risk management activities and risk assessments according to company procedures and applicable regulations.
Support the manager in drafting and reviewing documents shared with clients as QTA, declatation, questionnairs.
Support activities aimed to identify and solve possible product quality and registrations issues.
Requirements
Main Requirements:
Degree in a scientific discipline (Chemical, CTF or similar)
At least 3 years of experience in the pharmaceutical industry with QA topics
Previous experience in QC or Regulatory is a plus
Fluent English and Italian oral and written communication
Computer skills (word, excel, power point, LIMS, TW)
Soft skills:
Good verbal and written communication skills
Problem-solving skills and result orientation
Proactive, teamwork skills and flexibility
Able to work with a good level of autonomy with supervision where necessary
