Senior Compliance Scientist, Annual Product Review Job

SENIOR COMPLIANCE SCIENTIST, ANNUAL PRODUCT REVIEW needed for a CONTRACT opportunity with Yoh's client located in East Hanover, NJ.

THE BIG PICTURE - TOP SKILLS SHOULD YOU POSSESS:

- Quality Assurance
- cGMP
- ICH guidelines

WHAT YOU'LL BE DOING:

- Responsible for the preparation of the Annual Product Review Reports according to the established schedule.
- Responsible for the compilation and data interpretation of analytical, manufacturing and regulatory data.
- Responsible to draw conclusions from Real Time data and statistical reports.
- Responsible to ensure that established testing control procedures are followed.
- Responsible for serving on various project teams to fulfil activities as assigned.
- Responsible for writing and updating applicable SOP's.
- Responsible for maintaining APQR schedule.
- Responsible for the Annual Product Review Report record keeping.
- Responsible for the scheduling meetings with the APR team to determine the follow-up action items.

WHAT YOU NEED TO BRING TO THE TABLE:

- Bachelors/Masters of Science degree in a science, analytical field, and pharmaceutical industry.
- Minimum 5 years in the pharmaceutical industry with an emphasis on Quality Assurance.
- Applicable PC software knowledge and prior experience with DRAGON, T EDI. SAP. LIMS (Laboratory l information Management).
- Knowledge of cGMPs. (ICH Guidelines).
- Possess the ability to manage multiple projects and work independently in ambiguous situations.
- Excellent technical writing skills and the ability to manage data is required.
- Strong analytical background.

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER:Hannah Cihlar

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: SCIENTIFIC, CLINICAL, MONJOB

TAXTERM: CON_W2J2WMIDATL

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SFSF: LS