About the job

ProductLife Group is looking for CMC Associate to join our team in Tunisia

About us

Group 10
Responsibilities

As CMC Associate you will have the opportunity to assist with:

Prepare CMC regulatory documents within established timelines (Modules 2.3 & 3.2, IMPD, variations)

Analyze and / or write scientific reports from the raw data provided by the client.

Regulatory compliance: comparison of analytical procedures and / or manufacturing process between MA dossier and manufacturing site procedures.

Provide on-going support to the CMC Leader and to project teams to ensure that project objectives are met.

Assist in the preparation or update of Standard Operating Procedures (SOPs) and Working Practice Documents (WPDs)

Group 11
Education and Experience

Bachelor’s degree in life Science/ Pharmacy related field

0-2 years of experience in CMC and/ or Quality Assurance in Pharmaceutical Industry

Knowledge of EU regulations for pharmaceuticals

Group 13
Skills

Fluent in English/ French (written &spoken)

Excellent attention to detail

Ability to work well within a team

Good time management skills

Ability to work to tight deadlines

Process oriented

Excellent communication skills

CMC Associate 448