Quality Disposition Assoc III - EMQO

This job is no longer active. View similar jobs.

POST DATE 9/9/2016
END DATE 10/12/2016

Eisai Raleigh, NC

Company
Eisai
Job Classification
Full Time
Company Ref #
3831BR
AJE Ref #
576124397
Location
Raleigh, NC
Experience
Mid-Career (2 - 15 years)
Job Type
Regular
Education
Bachelors Degree

JOB DESCRIPTION

APPLY
Department Name
RTP EMO QA

Location/Territory Name
Raleigh, NC

Job Description
RESPONSIBILITES

Performs Label, Master Batch and Lot Record Review and Approval

Reviews executed production records and assigns the appropriate Disposition

Conducts and documents investigations into deviations or complaints

Authors/prepares Annual Product Reviews/Product Quality Reviews

Provides support for Regulatory Agency audits

The position independently determines whether the product manufactured by Eisai meets standards and is acceptable for distribution to Eisai Patients.

Job Qualifications
KNOWLEDGE/SKILLS/ABILITIES REQUIRED

Bachelor s degree (preferably in science related discipline)

8+ years of pharmaceutical/biotech experience

Strong oral and written communication skills.

Ability to interpret and apply GMPs, relevant laws, guidance documents and directives to extremely complex pharmaceutical situations.

Attention to detail, ability to coordinate investigations with multiple functional groups with a sense of urgency.

Exercises independent judgment in evaluating product disposition.

Auto req ID
3831BR

Job Type
Full-time



Eisai is an Equal Opportunity Employer Minority / Female / Disability / Vet