Quality Compliance Officer
3 weeks ago
ORGANISATION
Clinigen Limited is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses. Our divisions operate in a complex global regulatory environment and ensure that vital medicines are delivered securely, on time and wherever they are needed in the world.
We are currently 1,100 people, headquartered in the UK, with sites in Burton-on-Trent and Weybridge, with global offices in the US, EU, Australia, New Zealand, Japan, Hong Kong, South Africa, and South East Asia. Clinigen has grown rapidly since it began in 2010 and is positioned well for an exciting future of continued growth. To sustain our growth, we’re on the lookout for motivated, ambitious and committed individuals to join our highly successful global team.
ROLE
**Job Profile**: As a member of the Quality Compliance team, ensure compliance functions are carried out in line with domestic licence obligations. Provide comprehensive support to internal customers who require compliance-based advice.
**Reporting to**:Quality Compliance Manager
**Direct Reports**:None
***
**Key Responsibilities**:
- Processing of daily import notifications and subsequent acknowledgements, inc. Objections and further information requests.
- Contribute to the management and review of NOI inventory planning levels in line with business and patient demand.
- Ensure cover for all operational daily compliance duties in co-operation with colleagues.
- Generation of country specific notifications.
- Creation/Maintenance of Quality Compliance ERP Components.
- Internal and External processing of Special Clinical Needs letters, including processing of urgent requests.
- Participate in projects to implement new, or improve existing Quality Compliance processes.
- Support maintenance of team procedures.
- Preliminary horizon scanning of Quality/Regulatory websites and resources.
- Support business in resolution of item queries due to discrepancies.
- Develop and provide internal training related to Quality Compliance processes.
**Additional Duties**
- The list of duties is not intended to be exhaustive, but gives a general indication of the tasks involved. It is the nature of the company that tasks and responsibilities are, in many circumstances, unpredictable and varied. All employees are, therefore, expected to work in a flexible way when the occasion arises and acknowledge that tasks not specifically covered in their job description are not excluded.
**REQUIREMENTS**:
**Requirements**:
- GCSE Grade C or above in English and Math.
- A strong working knowledge of GMP and GDP.
- Excellent written and verbal communication.
- Knowledge of Unlicensed Medicines (Specials).
- Proven ability of accurate and timely completion of tasks.
- Proven ability of being able to prioritise and multitask.
**BENEFITS**:
- 27 days holiday plus 8 bank holidays
- Pension contributions 4.5% matched
- Life assurance 4 x annual salary
- Flexible Benefits Platform with £25/month Company contribution
- Annual salary review
- Independent financial advice service
- Enhanced Employee Assistance Programme
- Shopping discounts with retailers
- Long service awards
- Recognition scheme & employee of the year awards
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