QA Specialist - Cell Therapy GMP - London

Paramount Recruitment Ltd


Job ID :

13644


Company Type :

Staffing Firms


Industry :

Science and Research


Education Level :

Bsc,Master of Science,phD


Address 1 :

United Kingdom,London,London,


Key Skills :

Quality Assurance


Salary :

Negotiable


Date Posted :

27 Nov, 2018



Company Name :

Paramount Recruitment Ltd


Location1 :

London




Job Category :

Scientific Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

negotiable





Description

QA Associate - Cell Therapy - London

A fantastic opportunity has arisen for a QA Associate - Cell Therapy to join an expanding clinical stage biotechnology company in London. As an organisation they are committed to developing next generation, patient specific therapies, bringing together strong expertise across cancer evolution, bioinformatics and cellular therapy.

You would play a key role in establishing, growing and maintaining the quality systems and processes for the whole organisation which has satellite sites in two other London locations. A hands-on approach is essential and it is expected that the successful candidate will work with the manufacturing and QC teams to implement and develop key documents and support of the clinical and regulatory departments in compliance with regulatory requirements and compliance with the company QMS.

Responsibilities
-Support the QMS ensuring activities conform with regulatory requirements
-Assist in routine QA duties and audits to ensure GxP & HTA compliance plus other regulatory requirements relating to manufacture and clinical trials for cellular therapies and ATIMPs including:

odocument control system
ochange controls
ocorrective and preventative actions (CAPA)
odeviation & out of specification (OOS) reporting
ocalibration and maintenance
oqualification & validation
ointernal audits
ovendor qualification including external audits as necessary
oDevelop and review Quality and GxP related documentation

-Assist in the management of Product Specification Files for ATIMP's
-Support the Implementing and Maintaining of training records for the company and training structures and requirements as the company grows.
-Support the implementing of systems from a quality perspective to ensure ATIMP traceability and responsibility
-Ensuring efficient quality systems supporting logistical aspects product and sample transport and handling
-Advising in the preparation of validation protocols and reports and review of data generated in the execution of validation protocols.
-Working closely with the manufacturing and QC teams to establish key manufacturing documentation in line with a Contract Manufacturing Organisation's own QM system

Essential experience
-3 years' experience working in QA in a biopharmaceutical GMP environment.
-Experience in setting up and managing robust Quality Management systems ensure GxP compliance
-Good working knowledge of the tissues and cells directive
-Experience of working with contract manufacturing companies
-Technical knowledge of quality requirements for manufacturing processes and laboratory techniques
-English Language skills
-Good working knowledge of using Microsoft Office programs

Desired experience
-A working knowledge of regulatory requirements that specifically apply for the manufacture and/or testing of cell therapy products and/or ATMP's
-An understanding of GCP, GCLP, GDP and HTA requirements
-Experience of auditing key raw material suppliers as to GMP compliance.
-Experience in vendor and site audits
-Experience of training staff

Qualifications
-BSc or MSc in a biological subject


To find out more about this superb opportunity please contact myself, Lauren Gripton, of Paramount Recruitment on lgripton@pararecruit.com

Keywords- QA, quality assurance, quality, atmp, atmps. Advanced therapy medicinal products, cellular therapies, cell therapy, gene therapy, bsc, msc, gmp, manufacturing.

Paramount Recruitment Limited provides services as an agency and an employment business. We regularly have similar roles in this area. Please see our website for details or send your CV in to us to find out the latest opportunities.


Company Name:

Paramount Recruitment Ltd


Headquarters:

No. 5 Lower Temple Street,No. 5 Lower Temple Street


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

B1 1QU


Website:

www.paramountrecruitment.co.uk


Employees:

less than 100


Industry:

Pharmaceutical Recruitment


City:

Birmingham


Phone No. :

+44 (0)121 616 3460


Specialist in Permanent, Contract and Interim recruitment solutions to the Pharmaceutical and Life Science industries throughout Europe.

Our goal is to assist our candidates in finding that “perfect fit” between individual skills and experience and the right career opportunity. We identify and only present the positions that accurately reflect a chosen professional path. We discuss opportunities in detail, respect choices and ask permission prior to presenting any details to prospective clients. We brief and prepare every candidate for client meetings, and once the interview process is complete, provide feedback in a timely manner.

Our clients choose Paramount because:
• We are a Corporate Member of REC (Recently Inspected)
• We aspire to build long-term partnerships
• Our consultants are highly trained with expert market knowledge
• We are one of the most effective advertisers on the Internet
• We provide tailored Recruitment Solutions
• We keep up-to-date with Industry information – Salary scales, market knowledge, skills shortages

For more information,visit www.paramountrecruitment.co.uk.

View all Paramount Recruitment Ltd Jobs

Established in January 2003, Paramount Recruitment is an independent recruitment consultancy which has grown to be one of the leading recruiters to the Healthcare, Pharmaceutical and Scientific industries, throughout the UK and Europe.

Our Vision is to be internationally recognised and admired as the number one recruitment solutions provider to the Healthcare Pharmaceutical and Scientific industries.

Our Mission is to employ the best Consultants, whose aim is to deliver a professional and superior service to ensure our clients achieve their business goals and our candidates attain their career aspirations.
 
Our Values define who we are as an organisation and what makes us different. They influence the way we work with each other – and the way we serve our clients and candidates:

  • Respect - Paramount people listen, engage and contribute to ensure we make  the best possible decisions.  We are proud to work in recruitment.  Our diversity    makes our team uniquely adaptable to whatever challenges be it location, industry or culture we work in.
  • Integrity - Credibility means everything.  We are honest and transparent in our approach with everyone.
  • Entrepreneurial - We make it our business to excel when others can’t.  We relish the opportunity of a challenge using innovative and unique solutions.  We strive to be the agency of choice.
  • Experts Continuous knowledge building and sharing is central to our success.  We work in partnership with clients and candidates, our combined knowledge of industry and recruitment ensures we match the right person to the right job at the right time.
  • Success – At Paramount we recognise and reward achievement, we nurture an environment where people can fulfil and maximise their potential.

View All Paramount Recruitment Ltd Jobs



© 2018 Jobsinpharma - 4ward Technologies Ltd All rights reserved.