Quality Assurance Auditor/Inspector

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 Quality Assurance Auditor/Inspector, to work in Elizabeth, New Jersey. There are currently, 2 QA Inspector/Auditor positions available for the 1st (7:45 ? 4:15) and 2nd (4:15 ? 12:30) shifts.

 

Responsibilities

Auditor

?  Aid in the investigation of Customer Complaint investigations.

?  Audits records to ensure compliance with the approved master formula.

?  Audits records to ensure compliance with 21CFR part 211 subpart F (Production and Process Control).

?  Evaluates quality impact of process deviations.

?  Reviews and approves release status of batches to packaging.

?  Identifies the need for investigations for deviations.

?  Provides notification of batch status to QA and Production management.

?  Provides training for Batch Record auditing.

?  Maintains QA records, for example, logbooks, hold notice, as require by established quality systems.

 

Inspector (as necessary)

?  Performs in process testing during the manufacturing process, for example, weight variations and friability.

?  Perform room and equipment clearances.

?  Provides support for the maintenance of retain, hold, and reject areas.

?  Performs swab sampling as required for Cleaning Validations.

?  Provides notification of manufacturing deviations to QA and Production management.

?  Works as an integrated team member with Production.

 

Requirements

 

?  Bachelor?s degree in a science discipline or equivalent work experience required.

?  1 ? 3+ years experience working in a Quality with a solid dose pharmaceutical manufacturer.

?  Must be well organized, detail-oriented, and experienced in working with minimal supervision.

?  Must possess excellent verbal and written communication skills.

?  Experience using Microsoft Office applications, including Word and Excel, and data entry experience is a plus.

?  Must have the ability and willingness to interact and work with various individuals at all levels in the organization.

?  Ability and willingness to work overtime, including Saturdays and Sundays.

?  Ability and willingness to work rotating shifts as needed.

?  Ability to lift 40 pounds.

?  Should have desire to cross-train within related QA functions and flexibility to learn other job responsibilities.

 

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: QA Aud/Insp-MD ? MB).

 

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