Sr Compliance Analyst - FWN

Job description

Job Description

Serve as a multi-functional team member, representing manufacturing for the review of manufacturing/control sections of NDAs, ANDAs, 510K and technical files, PPCs, PCRs, RCRs, CPDS, ECNs and technical protocols. Support the plant internal assessment program as required for QA Compliance. Ensure that customer and regulatory requirements are implemented. May act as final control checkpoint, write product specifications and quality procedures. May also deal with the acceptability of labeling and packaging materials, maintaining an inspection and approval system, perform investigations and recommend solutions to manufacturing processes.

EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.

Desired profile

Minimum requirements

Bachelors Degree in in Biology, Chemistry, or Engineering

Fluent in English

7 years in medical device, drug industry.
Familiar with Medical Device QSRs, Drug GMPs, ISO 9001 and EN 46002 standards CMDR and Medical Device Directive.
Must possess strong interpersonal and auditing skills.
Must be proficient in relational database and word processing software.