Pharmaceutical Jobs - Clinical Research Jobs

Position

Quality Assurance Manager & Qualified Person

Company

i-Pharm Consulting

Location

Northumberland

Country

United Kingdom

Job Description

Quality Pharmaceutical Services Manager (Qualified Person) – International Contract Manufacturing Organisation – Excellent Benefits
SUMMARY
There is now an excellent opportunity for an experienced Quality Assurance Manager and Qualified Person to join this forward thinking organisation in a senior position that will see you being the driving force behind this leading edge company. Working within an extremely passionate team and having your ideas welcomed and actioned, this really is the place to be for an enthusiastic and progressive individual.
JOB TITLE: Quality Assurance Manager / Qualified Person / Quality Assurance GMP / cGMP / GCP / Pharmaceutical Services Manager

LOCATION: The Northeast

COMPANY STATEMENT: This is an international pharmaceutical company who specialise in a number of market leading niche products. They have been growing continually and are at the forefront of their field. They are looking for bright, enthusiastic and innovative individuals who will grow and develop with the company. Based in a beautiful part of the world and offering excellent benefits, they are looking for individuals who are looking for their next career move.

SALARY: Negotiable

ROLE/DESCRIPTION:
The Quality Services Manager will need to have prior experience of Quality Management and also be a registered Qualified Person (Investigational Medicinal Products release). You will be heading up a team of like-minded individuals in this risk-assessment focussed company developing strategies to drive the quality department forward. Working in a sterile environment with a range of dosage formats you will be manufacturing to supply clinical trials. Reporting directly to the Quality Director whom you will be working with as opposed to for you will be a crucial element in driving this company forward.
• Must have the following:-
– QP
– QA Management experience
– Clinical trial supply experience
– MHRA/FDA experience
– Energetic, entrepreneurial attitude to making change happen
– Best in class EU and US GMP regulations knowledge
• Strong candidates will have:-
– Pharmacovigilance experience
– Experience of importing pharma products from outside EU
– Strong auditing skills
– Hosted customer and regulatory audits
– Lean six sigma knowledge
• Position is responsible for:-
– All QA support to Clinical Trial manufacturing, packaging and distribution business
– All QA support to pharmaceutical development service
– All EU importation services inc pharmacovigilance
– Commercial QP release of packed OSDs
– Stand-in to site Quality Director
• Key goals for 2009:-
– Establish a class leading CTS function that delivers compliance at the right cost and at the right time
– Keeps OTIF >95% and seeks year on year 10% cost savings
– Manages and passes RFT all customer audits
– Establishes OTIF for QP release of imported product
– Team member in facility and business expansion
– Establishes function, mentors and grows QA officers

ABOUT i-PHARM CONSULTING

i-Pharm Consulting is a specialist Recruitment Company servicing the Pharmaceutical industry in the UK and Europe. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance and Bioinformatics.

www.i-pharmconsulting.com

TO APPLY

If you would like to discuss this vacancy further, please call Principal Consultant Lauren Bell-Misri on +44 (0)20 3189 2299, or email lbell-misri@i-pharmconsulting.com. If this role is not suitable, Lauren is also available to discuss other possible positions or answer any general questions regarding your career and the current market.

KEY WORDS:

Quality Assurance Manager, Qualified Person, Quality Assurance GMP, cGMP, IMP, Investigational Medicinal Products, GCP, cGCP, Pharmaceutical Services Manager

Company Profile

About i-Pharm Consulting i-Pharm Consulting is a specialist Recruitment Company servicing the Pharmaceutical industry in the UK and Europe. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs). The company itself was formed by a number of experienced and like-minded recruitment specialists who have very significant and wide-ranging industry knowledge, gained over the last 20 years. This experience combined with our radical approach has ensured a strong desire to improve service standards and our success in achieving this is what our clients say, sets us apart from other suppliers. The i-Pharm approach is based on 2 key principles - our ability to deliver and our integrity in doing so.

Job Type

Full Time

Salary

From 40000 To 60000 £ Per Annum

Skills Required

Quality Assurance Management

Reference

SC28

Posted On

20 November 2009

Last Date to Apply

20 July 2010

Important Notice

For jobs based in the EU it is unlawful to employ a person who does not have permission to live and work in the EU. Unless the job advert states otherwise, please ensure you have this permission before applying.

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