CMC Officer 318

CMC Officer 318

004-placeholder India, Morocco, Tunisia - Remote work possible - Product Development - Biopharmaceutical Drug Development services - 003-clock Permanent contract PL Group is seeking a CMC Officer to join our dynamic team and support the activities carried out in our Hub.

Specific activities and responsibilities:

1. Prepare, review and dispatch of international market variations
2. Coordination with client
3. Managing and updating the internal and external tools
4. Timely update and maintain the trackers

Required experience:

At least 6 years A CMC profile with international market quality variation experience is preferred. (Additionally EU quality variation experience and knowledge of variation module 1will be a Bonus)

Required technical skills:

1. Knowledge of the quality variation (module 3 writing)
2. Capable to prepare and review quality documents
3. Knowledge of the European/international guidelines
4. Good knowledge of MS office, share point

Additional experience and/or skills:

1. Time management
2. Work prioritization
3. Good communication – Good level in English
4. Quick learner
5. Good organization
6. Team spirit

CMC Officer 318

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