Clinical QA Manager

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Clinical QA Manager will be varied however the key duties and responsibilities are as follows:

1.

Ensures compliance of clinical studies with internal SOPs and clinical plans as well as with applicable worldwide regulations and guidelines to ensure adherence to GCP in conduct of clinical trials and the quality and integrity of generated data.

2.

Provide GCP/GCLP/GLP guidance as appropriate to clinical project teams, including risk identification/mitigation of potential of identified operational issues/deviations

3.

Planning and implementing regular GCP training and other quality related clinical training

4.

Participate in project meetings (internal and external) as Clinical Quality representative.



ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Clinical QA Manager we are looking to identify the following on your profile and past history:

1.

Relevant degree in a Life Sciences, Pharmacy, Regulatory

2.

Proven industry experience conducting both internal and external Audits.



3.

A working knowledge and practical experience in the pharmaceutical/biotechnology industry in a GCP QA role.

(5 years minimum).

Key Words: GCP, Clinical Trials, biologics, pharmaceutical, QMS, QA, Quality Assurance, GxP, Documentation




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