Clinical Compliance Specialist

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