Principal Auditor

i Pharm Consulting Ltd
13 Nov 2017
16 Nov 2017
Contract Type
Full Time
i-Pharm has partnered with an international company in the pharmaceutical industry to hire a Principal GMDP Quality Auditor on a permanent basis in Cambridge.

The main focus of this position is to provide information and support across all areas of the business as required, including maintaining good working relationships and undertaking GMDP audits in support of the company's global audit program, across multiple therapy areas.

ROLE RESPONSIBILITIES (including but not limited to):
*Conducting audits of manufacturers, suppliers, warehouse and distribution centres, including medicinal and non-medicinal products, API, packaging, raw materials and distributors
*Preparing reports, communicating with suppliers and circulating the report internally in a timely manner
*Working cross functionally to ensure the product can be compliantly distributed to market in support of product demand
*Ensuring compliance with statutory duties, regulations and legislation
*Contributing to projects as required
*Contributing to and assisting in the completion of Technical/Quality Agreements
*Continuously driving for improvement
*Providing support and advice on Quality matters to customers
*Contributing to best practice
*Participating in strategic projects including new product introductions and new supplier approvals
*Assisting with generation and interpretation of quality metrics

*Strong experience of GMDP auditing of low/medium risk and less complex product types
*Experience in the assessment of 3rd parties in compliance with GMDP guidelines across multiple dosage forms
*A strong knowledge of all GMDP and associated guidelines and an appreciation of the differences between them
*Efficient report writing skills
*Excellent written and oral communication skills
*Effective time management skills
*Trained and certified as a Lead Auditor by a recognised professional body

i-Pharm Consulting is a specialist Recruitment Company servicing the Pharmaceutical industry in the UK and Europe. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance and Bioinformatics.

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If you would like to discuss this vacancy further, please call Senior Delivery Consultant Rebecca Sparkes on Phone number removed or email Email address removed. If this role is not suitable, Rebecca is also available to discuss other possible positions or answer any general questions regarding your career and the current market.

GMDP / Cambridge / Pharma / Pharmaceutical / Auditor / Senior Auditor / Principal Auditor / Permanent / Auditing / Auditing Program / Legislation