Qualified Person - Peabody, MA, United States - Nexus Innovations

Nexus Innovations

Verified Company

Peabody, MA, United States

2 weeks ago

Posted by:

James Miller

beBee Recruiter

Freelance

Description

We are currently looking for:
Qualified Person (m/f/d) Pharma in Rosenheim, Peabody, MA:

We are seeking a Qualified Person (m/f/d) for an established pharmaceutical company.

SGK LIFE SCIENCES CONSULTING:

We are an owner-managed company and personnel consulting firm in the life sciences industry and healthcare sector. Our focus is on specialized personnel recruitment, compensation consulting, and the development of career models for scientifically-driven companies.

We are excited about your interest and welcome your contact via email or phone.

YOUR RESPONSIBILITIES:

Fulfilling the duties of a Qualified Person according to 14 AMG and Annex 16 EU-GMP guidelines
Release of bulk and finished products, as well as maintaining a continuous register of all released batches according to 19 AMG in connection with 17 AMWHV
Evaluation and approval of legally required product and/or batchrelated documents, such as PQRs, stability reports
Participation and evaluation of deviations and change control requests (e.g. for introduction of new products)
Monitoring of GMPcompliant and registrationcompliant manufacturing and testing of pharmaceuticals
Participation in quality assurance agreements, responsibility agreements, audits, and inspections
Review and approval of documents within the scope of responsibility

YOUR PROFILE:

Completed university degree with several years of professional experience in quality management, quality assurance, GMP production, or quality control in the