CMC Officer/Specialist 823

ProductLife Group is looking for a CMC Officer/Specialist to join our dynamic team in Tunisia.

About us

Responsibilities

Prepares CMC regulatory documents (full Module 3, Quality Overall Summary, IMPD, variation files)
Reviews CMC regulatory documents (full Module 3, Quality Overall Summary, IMPD, variation files)
Defines strategies for writing documents,
Defines positioning for variation files,
Evaluates the conformity of CMC documents according to the state of the art, current guidelines, local requirements and customer directives by performing gap analysis of regulatory documents.
Advises on pharmaceutical development: analysis of validation or stability reports.
Proposes to the client a strategy for validation, choice of specifications, stability plan.
Analyses and/or writes scientific reports based on raw data provided by the client
Regulatory compliance: comparison of analytical techniques and/or manufacturing processes between the MA file and factory procedures.
Carries out continuous regulatory monitoring/regulatory intelligence and communicates this to the teams
Contributes to the support and training of newcomers and colleagues (methodology, feedback,
tools)
Applies internal processes and templates as well as best practices of the profession
Reports any deviation or problem to his/her manager and proposes corrective or preventive actions
Contributes to the drafting of processes / procedures and templates to serve the performance of consulting activities

We are looking for someone with the following qualities:

Knowledge of the module 3 writing, variation life cycle management

Knowledge of the European guidelines

Manage simple and complex projects.

Capabilities to assess change controls

Management of the time

Good communication

Good organization

Good IT knowledge : pack office, share point, …