Compliance Officer - Reg And QA

South East England
£35000 - £36000 per annum + benefits. neg DOE
22 Feb 2013
22 Mar 2013
RE-12454381
Jade Tetlow
Healthcare
Operations
Permanent
Full Time

Based at their site in the South East you will report to the Head of Regulatory Affairs and QA.

They are looking for bright, ambitious energetic individuals to join their team. This is a fantastic opportunity to join an amazing company with the potential of global career progression. You will also be involved with improvement projects where you can really make a mark within this international company.

Some responsibilities include:

- Ensuring the regulatory departments awareness of Regulatory legislation, national requirements and guidance in the UK and Ireland.

- To carry out departmental training to cover any changes to legislation, guidance, authority best practices and internal company (global and local) procedural changes.

- Responsible for ensuring on time implementation of packaging material into the marketed packs following regulatory approval.

- Ensuring robust systems in place for tracking and monitoring artwork through from submission to implementation in alignment with regulatory affairs associates.

- Ensure Head of Regulatory Affairs is aware of any potential system gaps and risks of non compliance.

- Making clear mock-up/artwork requests using relevant best practice documents (internal and external), proofing their accuracy with regards to licence compliance and performing final review and approval prior to implementation in line with company standard lead times and business requirements.

- Coordinating all local approvals of packaging materials with relevant associates in line with company standard lead times and business requirements.

- Manage and track departmental activities through the corporate Trackwise system to communicate and coordinate submissions and actions take place on time.

- Entries into Trackwise to be checked for correctness and completeness to ensure efficient change control.


You must have:

- 1 - 2 years experience in regulatory affairs or quality assurance.
- Excellent organisational, verbal, written and communication skills and the ability to work under pressure to tight deadlines.
- Life Science degree (desirable)

Salary is up to £35k plus benefits but is negotiable for the right candidate.

If you are interested in the position please send an updated CV to Jade Tetlow or call 0207 758 7311 for further details I would be happy to discuss.

To find out more about Real please visit www.realstaffing.com