Hikma, a leading provider of affordable medicines, is seeking an experienced professional to join its Quality Systems Department.
Main Responsibilities:
* Investigate and trend reports for quality complaints from customers and suppliers
* Conduct risk assessments according to the company's quality management approach
* Monitor key performance indicators (KPIs) and prepare reports for corporate and quality councils
* Manage change controls, including introduction of information in databases, follow-up on pending actions, and archiving of closed change controls
* Oversee all change controls opened on Veeva QMS system; issue red-tags, stop notices, and risk assessments for batch release
* Act as document controller in Veeva DMS, overseeing document finalization by reviewing metadata fields; maintain database organized and oversee documentation to ensure conclusion and approval/effectiveness
* Approve infrastructure/maintenance forms
* Manage reserve sample inspection/incineration program and issue annual inspection calendar
* Issue general and product-specific manufacturing process yields for products manufactured at Hikma Farmacêutica (Portugal), S.A.
* Provide individual training on updated procedures according to approved training plans
Required Skills and Qualifications:
* Bachelor's degree or equivalent in science
* At least 6 months of professional experience or training in quality
* Good knowledge of English
* Familiarity with applicable guidelines
* Strong sense of responsibility
* Able to multitask and be highly organized
* Demonstrated ability in time management and flexibility in establishing priorities
* Computer skills, including experience in managing databases
Benefits:
* Direct contract with Hikma
* Salary commensurate with position
* Life insurance
* Health insurance
* Annual performance bonus
* Opportunities for career advancement