Description
Compliance Specialist – Distribution & EU operations is required by a global biopharma company on a contract to to assist in work towards the improvement of the regulatory process in European countries. Working closely with the distribution and compliance specialists, this role will involve sharing information & expertise, to visualise improvements in the current processes and system within GDP/ Quality and regulatory. Involving travel to Italy, France, Germany, Spain and Belgium to complete workshops/ implementation at deep level .The Compliance Specialist will support the Global Customer Operations function and will be responsible for the successful, timely completion of goals and objectives, which will strengthen the International Customer Operations organisation.
The individual will be required to conduct deep-dive sessions with local EU affiliates and assess their current GDP Compliance against local and EU regulations. The individual will be required to make recommendations to Senior Management with regards to standardisation and possible enhancement of the Customer Operations function to ensure 100% GDP Compliance in all areas.
This will be a hands on role with the individual expected to manage a portion of the project and assist and provide guidance where new SOP’s or process are required to be implemented.
This is a 9 month Contract role.
Principal Responsibilities
- Extensive experience working in a QA/RP role
- Significant experience working in the biopharmaceutical industry
- Excellent interpersonal skills and professional skills to interact with contractors.
- Must be able to prioritise and multitask in a challenging environment
- Must be able to read, understand, speak and write technically and legibly in English
- Experience working with multiple sites/locations
- Experience interfacing with regulatory bodies or working on regulatory submissions
- Excellent administrative skills, including good proficiency in Word, Excel and PowerPoint.
- Enthusiasm and quality improvement orientation.
- Ability to work under deadlines
Qualifications
- Bachelor's Degree in physical /life science or pharmacy; Advanced degree preferable