Clinigen 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 looking for a dedicated and proactive Qualified Person to join our Quality team based at our Dublin Warehouse. In this pivotal role, you will be responsible for QP oversight of business activities, relating to contract manufacturers, suppliers and technical due diligence activities.
Requirements
- Eligible to act as a QP under directive 2001/83/EC (preferably under the permanent provisions)
- Experienced in aseptically produced sterile products and ideally lyophilized dosage form
- Ideally, experience of QP certification for release of clinical trial materials under directive 2001/20/EC inclusive of dosage form manufacturing and clinical packing
- Demonstrable business and commercial awareness combined with patient focus
- Experience of working independently and as part of a team
- Experience of working across multiple time zones and in global business cultures (particularly US and Japan)
- Must also have knowledge of:
- Directive 2001/20/EC as amended on the wholesale distribution of medicinal products for human use
- Official Guidelines on GDP of medicinal products for human use
- The conditions of the MIA for which he or she is nominated
- The products traded under the licence and the conditions necessary for their safe storage and distribution
- The categories of persons to whom products may be distributed
- Be familiar with any changes that may be introduced into legislation and any variations that may be granted in respect of the licence for which he/she is named as RP
- Comply with the expectations of their professional body in relation to CPD
- Ideally have experience of the Quality Assurance and regulatory environment for the supply of unlicensed medicines used to support patient needs when a licensed medicine alternative is not available. This could be in local or overseas countries
Benefits
- 27 days holiday plus 8 bank holidays
- Life assurance 4 x annual salary
- Annual salary review
- Independent financial advice service
- Long service awards
- Recognition scheme & employee of the year awards