CMC Specialist 321, 322

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

Specific activities and responsibilities:

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

Required experience:

At least 10 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. Strong knowledge of the quality variation (module 3 writing)
2. knowledge of the variation module 1 writing
3. Capable to prepare and review quality documents
4. Capable to define and share variation strategies
5. Knowledge of the European/international guidelines
6. Capable to manage simple and complex quality projects
7. Capable to assess change controls
8. 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. Good pedagogue
7. Team spirit

CMC Specialist 321, 322

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