Qualifed Person
- Arbeidsgiver
- TPI Norway
- Stillingstittel
- Qualifed Person
- Frist
- 17.10.2018
- Ansettelsesform
- Fast
Qualified Person
TPI Norway are seeking a Qualified Person to join our API and CMO business based in Kragero Norway.
TPI is a rapidly growing global supplier of pain relief, cough and anti-addiction active pharmaceutical ingredients and solid oral dose tablets. We are a fully integrated opiate manufacturer from poppy cultivation to tablet production and pride ourselves on being the lowest cost narcotic raw material (NRM) and API manufacturer with novel water based extraction technology. The company was founded in 2004 and is listed on the Australian stock exchange. We have manufacturing sites in Victoria Australia and Kragero Norway.
Responsibilities:
This Qualified Person role is based in the API and CMO business unit and will act as a QP in accordance with EU GMP/GDP to provide final certification/release along with Quality Assurance and Regulatory support. You will perform audits of third party providers in order to ensure EU GMP standards have been achieved and will support the internal audit programme to enable permanent inspection readiness.
Person Specification:
It is essential that you are a fully qualified QP and that you are experienced with final certification/release of API and solid oral dosage manufacture. Quality systems management, audit experience (internal and external), a good knowledge of Quality Systems (compliance, CAPA, continuous improvement) and distribution are essential for this role. A strong EU regulatory understanding would be advantageous.
The ideal candidate will have the experience and the confidence to interact with Production and QA/QC and will have the strength of character to lead and facilitate change in these areas. Generics QP experience would be an advantage but applications from QPs that have had exposure to a broad range of activities are welcome.
This is a key role for the company and is a sign of their ambition for the future. The position is full time, permanent and will be based on our Kragero site in Norway.
Apply now
For more information, please contact Annemieke Nesse, Headhunter Kelly Scientific Resources on +47 92208761