Qualified Person

Optimus Life Sciences
Northern Ireland
£750 - £1k p/day
13 Nov 2017
16 Nov 2017
Contract Type
Full Time
Location: Ireland

Salary - 700 - 1000 Euros per day

Our client has an excellent reputation in the pharmaceutical industry. The company is ranked as one of the best companies in the country to work for. Over the years the employees have sustained a culture that values integrity and respect for people.

They are in search of a new QP who can bring experience and knowledge.

About you:

Essential Qualifications, Skills & Experience:

* You will hold a Degree in Biology, Chemistry, Pharmacy or equivalent
* You will be trained in auditing practices
* You will be eligible to act as a Qualified Person (QP) in accordance with EU directive 2001/83/EC
* You will have knowledge of multiple dosage forms including sterile and non-sterile medicines across a multitude of presentations
* You will have experience in the auditing of API and Final Product manufacturing sites as a Lead Auditor
* You will be experienced and comfortable with the concept of parametric release
* You will have experience of hosting regulatory inspections and being able to clearly articulate how the company manages risk

Essential Attributes:

You will:

* Have high levels of pragmatism supported by factual risk based decision making capability
* Be knowledgeable of the unlicensed medicines industry 'Specials' and understand the historic development of the regulatory guidance within this space through to today's Q&As approach with the MHRA
* Have effective written and verbal communication skills
* Be trustworthy and conscientious
* Be an effective decision maker

Desirable Qualifications, Skills & Experience:

* Knowledge of ICH Q8 Pharmaceutical Development
* Have the ability to support a team of developing peers through product development projects working closely with the Operations Director