Hikma, a leading pharmaceutical company in the generics segment, is committed to meeting today's health needs with high quality products, accessible to everyone.
Due to the recent growth, we are looking for a Regulatory Compliance Specialist (m/f) for our Sintra facilities.
Accepting our challenge, we offer an initial and continuous training program integrated in a dynamic and positive environment.

Job description/Main Responsibilities:

Perform Internal audits to the 6 systems
Prepare and support external audits (Clients and Regulatory Authorities)
Manage the CAPAs from internal and external audits
Perform GAP analysis for the FDA 483’s and WL and determine if internal CAPAs are needed
Ensure compliance with the Corporate Policies
Give training in specific subjects related with Regulatory Compliance

Qualification/Experience:

Master Degree in Health Sciences, preferability in Pharmaceutical Sciences.
More than 3 years’ experience in the pharmaceutical Industry in the Quality area
Experience in injectables is a plus
English Advanced Level

Competencies:

Strong communication and organizational skills
Diligent, assertive, pro-active, self-motivated, detail oriented, capable to work under pressure and multi-tasking;
Positive attitude towards learning new skills and adapting to change
Good knowledge of Windows operating system, namely in the software Office (Word, Excel and Power Point)

If you think this is a good opportunity for your professional career, join us and contribute to better health, within reach, every day.