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GCP Auditor

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POST DATE 8/25/2016
END DATE 10/18/2016

Chiltern Trenton, NJ

Job Classification
Full Time
Company Ref #
Trenton, NJ
Mid-Career (2 - 15 years)
Job Type
Masters Degree
AJE Ref #






Be a part of a research-driven, global, integrated pharmaceutical company whose business has been structured into Drug Discovery, Branded Formulations, Generics Formulations and Active Pharmaceutical Ingredients (APIs). This is an In House position with a growing pharmaceutical company located in Mahwah, NJ.

The purpose of the role is to contribute to the success of the Glenmark clinical development program by assuring quality and compliance with internal and external (regulatory) standards. This includes providing quality assurance and audit support as well as support in quality management, inspection readiness and inspection conduct.


Audit planning, conduct and CAPA management

* Liaising with clinical development operations for awareness of the planned and ongoing clinical trial program.

* Development of a risk based audit schedule for all relevant aspects of a development program as well as system audits.

* Review of project related documentation such as protocol synopsis, protocol, investigator brochure, patient information sheet and informed consent forms etc.

* Conduct and report internal audits of Clinical Research and Development and external audits: CROs and vendors, investigator sites, etc.

* Track audit findings, corrective action and their implementation to completion.

* Maintain records as required for both internal and external auditing purposes.

* Provide support for the planning and implementation of clinical programs to clinical teams from a QA perspective.

Assist in the management of the Quality Management System for Clinical Research and Development and in the implementation of processes and systems to improve quality management in the GCP domain.

Assess and report on change controls and deviations to ensure adequate action is taken to rectify them and aim to prevent recurrence of the same type of deviations.

Conduct training on GCP and compliance related matters, including CAPA management and continuous improvement

Support GCP regulatory authority inspections and provide QA support for PV regulatory authority inspections and contribute to inspection readiness programs


Master of Science degree in relevant scientific discipline from a leading academic institution having excellent academic background

Approximately 5 years clinical development experience preferably with at least one year's experience of pharmaceutical or specialty pharmaceutical/biotech company or QA experience working with or in a vendor organisation (e.g. CRO)

At least 2 years experience in clinical QA

Fluent in English.

Experience in the conduct of different types of audits e.g. for cause audits, GCP audits or system audits

Knowledge of the interactions required by QA throughout the lifespan of a Clinical Trial

Knowledge of the responsibilities of those departments with whom clinical QA personnel will interact

Knowledge of pharmaceutical companies and vendor organisations

Knowledge of ICH GCP guidelines and of US FDA regulatory standards.

Chiltern is an EEO / AA Employer and is committed to providing opportunities to minorities, women, individuals with disabilities and veterans.

Chiltern is an EEO / AA Employer and is committed to providing opportunities to minorities, women, individuals with disabilities and veterans.




Full Time


Email Wanda Craddock