Clinical Compliance Specialist

IntegratedResourcesINC

Wayne, PA, United States contract

Posted: April 22, 2015

Job Description

A Few Words About Us
Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Job Responsibilities:

• To provide QA support for work performed at contract manufacturers and analytical laboratories for primarily for developmental/clinical use.

• To provide QA support for the manufacture, packaging and control of clinical trial materials to ensure compliance with GMP.

• To perform GMP release of IMP and ensure compliant release to other global markets as appropriate.

• To communicate with contractors/suppliers regarding technical information and queries.

• Ensure deviations/OOS are adequately investigated and documented.

• Ensure clinical complaints are adequately investigated and reported.

• To provide QA support for the manufacture, packaging and control of clinical trial materials to ensure compliance with GMP and IND/CTA requirements.

• Review and approve Master records, labels and protocols.

• Actively participate in project meetings as required.

• To be knowledgeable about the products supplied for clinical trials.

• University degree or equivalent in Chemistry, Biology, Pharmacy or other relevant science or an equivalent combination of education and experience – required

• Practical Experience of at least 4 years in a QA environment in the pharmaceutical industry – required.

• Practical clinical manufacturing/packaging environment experience – required

• Good understanding of GMP’s within a global environment – required

• Good understanding of Clinical Trial Manufacturing – required

• Good understanding of API manufacturing – preferred.

• Good technical and QA background having a good understanding of method development and validation, specification setting.

• Communicate effectively with contractors for technical information.

• Good technical and QA background having a good understanding of drug product development.

• Disposition certify and release IMP as required ensuring compliance

• Global QA

• Global Pharmaceutical Technology.

• Global Pharmaceutical Sciences (Product development and clinical supplies)

Amanpreet Kaur

Clinical Recruiter

Integrated Resources Inc.

IT LIFE SCIENCES ALLIED HEALTHCARE CRO

Inc. 5000 - 2007, 2008, 2009, 2010, 2011, 2012, 2013 & 2014 (8th Year)

Certified MBE I GSA - Schedule 66 I GSA - Schedule 621I I GSA - Schedule 70

(W) 732-429-1913| (F) 732-549-5549

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