Expert person - The College of New Jersey, United States - Apex Dynamics

Apex Dynamics

Verified Company

The College of New Jersey, United States

3 weeks ago

Posted by:

Meredith Sinclair

beBee Recruiter

Description

The College of New Jersey is one of the largest production sites of the Italian pharmaceutical company MENARINI GROUP, with over 400 employees.

We produce solid dosage forms (tablets, coated tablets, film-coated tablets, capsules) for various therapeutic areas and more than 100 markets worldwide in modern pharmaceutical facilities.

To support our team, we are looking for a:

Qualified Person (m/f/d) What to expect from us An exciting job in a traditional company driven by growth and backed by a global corporate network.

The opportunity to actively shape processes within the company. Flexibility in terms of working hours and location through flextime and home office. 30 days of vacation and entitlement to additional paid leave in accordance with collective agreements. Excellent access to public transportation and free employee parking. Discounted canteen meals and company health management. Your responsibilities Fulfilling the duties of a Qualified Person according to § 14 AMG and Annex 16 EU-GMP Guideline Batch certification Maintaining a continuous register of all released batches in accordance with § 19 AMG in conjunction with § 17 AMWHV Evaluation and approval of legally required product- and/or batch-related documents, such as PQRs, stability reports Processing and evaluation of deviations and change notifications Monitoring of GMP and registration-compliant manufacturing and testing of medicinal products according to AMG, AMHWV, and the EU GMP Guideline Participation in quality assurance agreements and responsibility agreements Participation in document creation, review,