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Quality Compliance Specialist - Auditor

HRS are seeking a Quality Compliance Specialist - Auditor to join a leading pharmaceutical company based in the Hertfordshire area.

As the Quality Compliance Specialist - Auditor you will be responsible for performing internal and external audits, and ensuring all activities meet the requirements of GMP and GLP regulations.



KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Quality Compliance Specialist - Auditor will be varied however the key duties and responsibilities are as follows:

1.

Write and review Technical and Quality Agreements to ensure responsibilities are define such that robust partnerships exist with suppliers and service providers.



2.

Review and respond to customer and third-party audit and self-assessment questionnaires.



3.

Perform internal audits and provide feedback to the Quality Audit Manager.

Identify gaps and facilitate improvements to systems and processes to ensure adherence to current GMP guidelines.



4.

Perform supplier audits and provide feedback to the Quality Audit Manager on the compliance of suppliers and service providers.



5.

To ensure that all activities meet the requirements of current GMP and GLP regulations.



ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Quality Compliance Specialist - Auditor, we are looking to identify the following on your profile and past history:

1.

Relevant science related degree or extensive relevant pharmaceutical experience within a GMP environment.



2.

Experience in performing internal and external audits to GMP, GDP, and ISO9001 Standards, and a good understanding of EU GMP and US CFR regulations and guidelines.

3.

Experience in planning and taking part in regulatory inspections.



Key Words: GMP | GLP | GDP | Audits | Auditing | Pharmaceutical | ISO9001 | Regulatory | CFR | Auditor | Quality Assurance | QA | Quality Compliance | Pharmacopoeial Standards |