Compliance Consultant, QMS - Bilingual

Compliance Consultant, QMS - Bilingual Pharmatech Associates Overview Description Pharmatech Associates is seeking Compliance Consultants to assist with performing gap assessments for quality management systems against US FDA requirements for companies looking to bring their products to the US market. The nature of our projects varies from client to client and can often be supported remotely; however, some may require trips to conduct site visits to locations outside the US.

Typical Project Responsibilities include:

Conducting gap assessments of a company's QMS against US FDA requirements with the aim of helping our clients pass a pre-approval inspection in support of ANDA, NDAs, and BLA submissions and providing prioritized remediation recommendations Evaluation of inspection readiness programs, including providing recommendations for improvement Remediation planning for various dosage form manufacturing facilities, including oral solid, liquid, and other non-sterile, as well as sterile, dosage forms Remediation of laboratory control systems Participate in complex root cause investigations, including manufacturing deviations and OOS investigations Educational/Experience Requirements include: B.S. in life sciences and 10 years' of relevant experience Demonstrated regulatory compliance expertise in one or more dosage forms as well as both drug products and active pharmaceutical ingredients Expert knowledge of current laws, regulations, and related to gaining approval for manufacturing drug products for the US market Bilingual or multi-lingual capabilities are a plus (e.g., Spanish, French, Portuguese) Ability to work with a team of consultants and manage work to a defined scope of work and meet timelines Superb written and oral communication skills Excellent interpersonal and soft skills Ability to solve problems using innovative techniques Pharmatech Associates, Inc. provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.