Aseptic Process Manager

hace 11 horas


San Juan, San Juan, Puerto Rico Qrc Group Llc A tiempo completo

At Qrc Group Llc, we are seeking a skilled Aseptic Process Manager to join our team.

The ideal candidate will have a strong background in aseptic pharmaceutical manufacturing and quality environments.

Responsibilities:

Support formulation, aseptic filling and sealing operations.

Lead and support aseptic process simulations.

Requirements:

Bachelor's Degree in a technical field is required.

Minimum 5 years of experience in aseptic pharmaceutical manufacturing and/or quality environment is required.

Thorough knowledge of GMPs and understanding in aseptic processing is required.

Bilingual (Spanish/English) is preferred.

Must be self-directed and requires an appropriate level of education and experience to make and act upon decisions that impact the site from an aseptic standpoint.

Working knowledge of 21CFR part 211 FDA regulations is required.

Knowledge of various quality and root cause analysis tools is preferred.

Prior investigation writing experience with determination of product impact is preferred.

MS Office skills are essential.



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