QA/ Regulatory Associate - N Yorkshire

CK Group
Kingston upon Hull
18 Feb 2018
02 Mar 2018
Contract Type
Full Time
Are you looking for an exciting opportunity to join a global CRO who are supporting the world's best pharmaceutical organisation in the development of new medicines? Are you an experienced GMP Auditor?
Naynesh Mistry is currently recruiting for Staff Associate (QA/Regulatory Associate) to join a leading drug development company based in Yorkshire on a permanent basis. This is a specialist role within the QA function, requiring substantial regulatory QA expertise.

My client requires the individual to have a strong regulatory QA experience as a Lead Auditor, with demonstrable experience of successful client interaction. External podium presentations at relevant regulatory meetings would be preferred. On offer is a competitive salary (£40,000 - £50,000 DOE) plus excellent benefits.

This role is responsible for defining and overseeing inspection program(s) that are operated to assure compliance of computerised systems, instrumentation, and electronic records. You will manage all aspects of such programmes, always ensuring that they are fully maintained in accordance with procedural requirements, and ensuring thorough follow up in terms of the close out of issues raised.

Responsibilities include but not limited to:
• Defines, manages, and executes compliance auditing programmes
• Fully competent as a Lead Auditor
• Trains others in the conduct of external and internal audits.
• Conducts specialist audits as necessary (multiple GxPs).

The successful candidate will have the following qualifications, skills and experiences:
• Bachelor of Science/Arts (BS/BA) degree (experience may be substituted for education in some circumstances).
• Intimate working knowledge of SOPs, P&Ps as well as local and international GLPs, cGMPs, GCPs and regulatory agency guidelines as applicable.
• Ability to confidently interact with clients and regulatory personnel, and conduct effective training sessions.
• Ability to effectively negotiate ideas and suggestions.
• Proven organization, observation, and problem solving skills

Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference SH40661 in all correspondence.

Similar jobs

Similar jobs