Batch Record Reviewer

 

 

Actavis ? creating value in pharmaceuticals

 

The Actavis Group is a leading player in the development, manufacture and sale of high-quality generic pharmaceuticals. The addition of Alpharma?s Human Generics business in late 2005 positions the Company as the fourth largest generic pharmaceutical company in the world, with 10,000 employees in 32 countries. Founded in 1956, the Group operates across five continents. Its headquarters are in Iceland.

 

Actavis is a fast growing company, headquartered in Iceland with modern development and manufacturing facilities in Europe, the US and Asia and an extensive sales and marketing network in five continents.  Actavis Group is now one of the five leading generic pharmaceutical companies in the world, with 10,000 employees in over 30 countries.  The Group offers one of the broadest portfolios in the generics sector and a wide variety of products in development and registration, enabling it to provide its customers with a wide range of affordable high quality pharmaceuticals.

 

Actavis is looking for individuals who are ambitious, pro-active and flexible enough to seize the opportunities around them. At Actavis we foster teamwork and value our resources, working efficiently to provide first class customer care.

 

Our U.S. Generics Division is currently searching for a Batch Record Reviewer to work in Elizabeth, New Jersey who will review manufacturing batch records for completeness, identifies deficiencies and resolves these as appropriate with production supervisors.

 

Responsibilities:

 

?  Reviews batch records to ensure compliance with the approved master formula.

?  Reviews batch records to ensure compliance with 21CFR part 211 subpart F Production and Process Control.

?  Evaluates quality impact of process deviations.

?  Tracks/trends batch record deviations.

?  Works closely with QA/Investigations group to resolve deviations.

?  In the event of issues in Manufacturing, works closely with supervisors to ensure timely resolution.

 

Requirements:

 

?  Minimum High School Diploma; BA/BS preferred.

?  3+ years pharmaceutical industry experience

?  QC inspection, documentation, and control experience or operations experience an asset.

?  Demonstrated ability to work with all levels of peers and management.

?  Detail orientation, organization skills, competent numeric skills, and PC literate.

?  Knowledge of cGMP for the pharmaceutical industry.

?  Strong communication (verbal/written) skills

 

 

We offer a competitive salary & a comprehensive benefits package to all eligible employees. Please e-mail your resume, cover letter & salary requirements to

www.recruiters@actavis.com (Att: Batch Rec Rev/MD ? MB).

 We are an Equal Opportunity Employer and appreciate diversity in our workforce.