Api Technical Specialist - Consultant

Descripción del Empleo:
CVG is a rapidly growing professional service company headquartered in Puerto Rico since 2012. We consult in the pharmaceutical, biotechnology, and medical device industries providing cGMP and industry best practices to our clients. Our family oriented culture strives to develop and leverage your interpersonal skills and technical experience for long term success. We are looking for consultants with strong experience in Active Pharmaceutical Ingredient (API).

This API Technical Specialist consultant role would use his/her knowledge of FDA cGMP, related regulations to Provide the pharmaceutical knowledge and technical support to the API plant. Provide support to the API plant to achieve require yields, standard costs, and typical quality attributes. Becomes knowledgeable in plant processes, procedures, and policies.
Requisitos:
Lead investigations of plant issues, determine root cause, and recommend preventive and corrective actions. Write the investigation report in the QTS software and route to obtain approvals. Initiate and direct projects to improve yield quality, safety, or productivity. Provide technical support for product transfers. Support and align with manufacturing unit goals and projects. Follow cGMP and data integrity requirements.

QUALIFICATIONS:
Over 5 years of experience working with product API.
Experience working with Quality in an FDA-regulated environment.
Great soft skills, excellent verbal and written communication
Positive personality and solution driven mantra is key
Effective time management, prioritization, and follow through

Required: MS in Organic Chemistry or related discipline.
Desirable: PhD in Organic Chemistry or related discipline.