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PQG Ref: 080407

There’s so many ways we can save lives.

And we’ve built a  new facility to prove it.

GSK

QA Manager Excellent Benefits Package

GlaxoSmithKline is one of the world’s leading pharmaceutical and healthcare companies. Our mission is to advance the quality of human life by enabling people to do more, feel better and live longer. With over 100 projects in clinical trials and many more in development, we take inspiration from the challenges we face – and from our dedication to innovation.

Our new Clinical Imaging Centre on the Hammersmith Hospital Campus is the first of its kind in Europe. It combines state-of-the-art non-invasive imaging modalities e.g. Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI) in a systematic manner with applications to drug discovery and development.

As part of a multidisciplinary team, you’ll oversee the quality function and promote a quality culture we can take pride in. You’ll also be in a position to influence the way new drugs are developed and implement Quality best practices at a new facility. Additional responsibilities will include:

• Development, implementation and maintenance of the GLP, GCP & GMP (GXP) quality systems for the new facility.
• Leading process improvement initiatives to implement QA processes which are efficient and evolve in line with changing business needs.
• Managing quality investigations arising from aberrant events pertaining to the manufacture and administration of parenteral PET products in clinical trials, to make recommendations for corrective and preventative actions, and to follow up on the implementation of those actions.
• Responsibility for assisting the Compliance Manager in coordinating and hosting external compliance and regulatory inspections, and internal GSK Compliance audits.
• Performing audits both internally and externally to evaluate compliance with the appropriate regulations and policies.
• Training of staff in GXP and quality procedures.

Without a doubt, it’s a challenging setting. We’ll be looking for a Science degree and a strong track record in quality assurance gained in the pharmaceutical or healthcare industries. Extensive knowledge, interpretation and application of quality management within a GXP environment will be essential, particularly in early phase clinical trials. QP status or eligibility in the EU would be an asset.

If you would like to apply for this role, visit our website http://www.gsk.com/careers quoting Req ID 47698. Closing date for applications: 18th April 2008.

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PQG Ref: 080331

Catalent

QUALITY OPPORTUNITIES at CATALENT

Catalent Pharma Solutions (formerly Cardinal Health Pharmaceutical Technologies and Services) is the leading provider of advanced technologies, and development, manufacturing and packaging services for pharmaceutical, biotechnology and consumer healthcare companies in nearly 100 countries. The company applies its local market expertise and technical creativity to advance treatments, change markets and enhance patient outcomes.  Catalent employs approximately 10,000 at more than 30 facilities worldwide and generates more than $1.7 billion in annual revenue.

The Catalent facility located in Bolton UK specialises in the packaging of pharmaceutical supplies for Investigational and Commercial use.  A number of exciting opportunities have arisen within the Quality function as a result of internal staff movements and our continued drive for growth and continuous improvement.  If you are a Quality professional with relevant experience in the following areas, we would like to hear from you:

  • General Quality experience supporting production activities in the pharma, food or other regulated industry
  • Quality Assurance experience as a QA supervisor, QA officer or QA assistant
  • Quality Management experience or a Qualified Person (directives 2001/20/EC or 2001/83/EC)
  • Qualification / Validation

If you feel you can contribute in this key area within a fast paced environment, bringing with you new experience to help drive the new business forward, send a CV and covering letter stating salary expectations and a description of how you feel you can contribute to clinicalsuk.hr@catalent.com or HR Department, Catalent Pharma Solutions, Lancaster Way, Wingates Industrial Park, Westhoughton, Bolton, B15 3XX.

Closing Date: 25 April 2008

______________________________________________________________________________________________________ PQG Ref: 080212
Custom Logo

Qualified Person (QP)

The UK side of an international commercial GMP joint venture, based in Elstree Hertfordshire, is looking for applications of interest from QPs with experience in cell culture facilities to take the responsibility for all aspects of quality management and training, either on consultancy or on a full-time basis.

This will involve the responsibilities for the management of the laboratory, training laboratory staff, quality control within the manufacturing and packaging department, the overseeing of the quality aspects of product development, and input into the validation processes involved in the commissioning of new equipment.

Please apply to:

Ian Graney,
CEO RMS Innovations UK Ltd.
Cephalon House, 8 Manor Park, Wildmere Road, Banbury, Oxon, OX16 3TB

igraney@neuro-technics.com

______________________________________________________________________________________________________ PQG Ref: 080208
Custom Logo

Quality Control (QC) Manager

An exciting opportunity to head up a growing QC laboratory recently transferred to brand new facilities within an expanding Pharmaceutical manufacturing company located on the South coast. You will have the opportunity to work in a fast paced environment where you will be managing and developing a team of analysts to achieve company goals and objectives.

Reporting to the Associate Director GMP QA, you will manage a growing team of 10 staff (working on two shifts) responsible for QC functions such as Raw Material and FPS testing, method development, method validation, and contract laboratory services, GMP, GLP, Health and Safety.

Strong organisational and multi tasking skills are required to ensure products are tested in accordance with specification and communication is key at all levels of the business to ensure sales targets are achieved. Reporting to Directors will be required on a regular basis.

You must have a strong chemistry background and be fully competent and experienced in Quality Control. Previous management experience is essential and you must have the proven ability to develop teams of people. You will also be capable of performing under pressure.

This expanding company will provide you with sufficient challenge and opportunity to satisfy the most ambitious professional.

An attractive package is available for the successful candidate, including pension, healthcare insurance, 23 days annual leave.

Please supply details in a covering letter with CV along with salary expectations to Carol Greenway, Custom Pharmaceuticals, Conway Street, Hove, East Sussex, BN3 3L ______________________________________________________________________________________________________