QC Analyst, Level 4 - 18 Month FTC

Posted 2 Days Ago
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Hengoed, Caerphilly, Wales
Mid level
Pharmaceutical
The Role
The QC Analyst will analyze starting materials, intermediates, and finished products while adhering to GCLP and GMP standards. Responsibilities include maintaining accurate records, proposing analytical method improvements, performing calibration checks, and solving any analytical problems. They will collaborate with other departments to address non-conformities and ensure compliance with established procedures.
Summary Generated by Built In

Description

Want a 3D Career? Join Norgine.

At Norgine, our colleagues Dare themselves to be different and try new things, Drive to achieve their goals and beyond, and Develop themselves and their community.

We call it the 3D career at Norgine and it offers you a fully-rounded experience with no limits.

Bring everything about yourself that you’re proud of, whether that’s your passion for making a difference, focus on others’ well-being, or intellectual curiosity to unleash in a fast-paced environment and supportive community.

In return, get a sense of belonging, a long-term career with ongoing development and upskilling, and a company that cares about people’s wellness as much as you do.

Because at Norgine, we transform lives with innovative healthcare solutions.

We have an exciting opportunity for a QC Analyst Level 4 to join Norgine on an 18 month FTC - contract.

The person holding this position will report to the QC Team Leader and be a member of the QC team.

Working a shift pattern of mornings and afternoons and 1 weekend in 4,

If you want a multi-dimensional 3D career in a leading healthcare organisation, join us.

Requirements

Main Tasks

  • Perform the analysis of starting materials, intermediates and finished products in accordance with written procedures.
  • Provide accurate records of work carried out.
  • Perform all duties in accordance with GCLP (Good Control Laboratory Practice), GMP (Good manufacturing Practice) and safe working practices.
  • Propose improvements to analytical methods or working practices and participate in department and company improvement projects
  • Perform calibration checks in accordance with written procedures.
  • Perform calculation checks on analysis records.
  • To carry out tasks as required to suit business needs and department needs and as appropriate to the job role.
  • Meet day to day and longer term schedules and performance objectives

Complexity

The products/materials handled are diverse in their nature and complexity. The job holder must have a wide range of analytical skills ranging from traditional wet chemistry to a working knowledge of modern instrumental techniques.

Although the tasks of the job holder are well covered by procedures and policies, a degree of initiative will be required in solving problems arising from analytical methods, particularly those associated with more sophisticated equipment.

Analysts receive direction from the Shift Team Leader - QC.

Accountability

The job holder is responsible for carrying out all work in accordance with written procedures.

He/she is responsible for informing the Shift Team Leader - QC of any non conformities discovered and for actively investigating any non-conformities with a view to establishing root cause.

He/she is responsible for keeping accurate, legible written records of their work and following GXP’s at all times

Relationships

Required to liaise with Operations, Global Technical, Pharmaceutical Development and Regulatory Affairs Departments on a variety of issues and information exchanges

Knowledge and Skills

Level 4 - Ideally qualified to degree level in chemistry or a life science. Lesser formal qualifications may be acceptable when coupled with substantial pharmaceutical analytical laboratory experience, in addition to level 3 responsibilities a level 4 analyst is required to have knowledge around analytical and equipment validation and data/report reviews and approval.

Skills / Experience

• Chromatographic Analysis

• Spectroscopic Analysis

• Oral Solid Dose Testing (including Dissolution, Disintegration, Hardness, etc)

• Pharmaceutical / Healthcare Experience

• Experience with Regulatory Bodies (FDA, MHRA, Etc)

• EXPERT USER – Analysis using Instruments

• Project work

• Writing/Amending SOP’s

• Experience with wet chemical techniques

• Analytical trouble shooting

• Use of Pharmacopoeias

• Use of balance and calibration

• Preparation of volumetric solutions and dilutions

• Input into Equipment and Method Validation

• Final data checks and data reporting for QC results

Benefits

Our benefits may vary per location. Please liaise with the Norgine TA representative to obtain more information.

Sound good? Find out more about the career you’ll have with Norgine, then apply here.


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Top Skills

Analytical Chemistry
The Company
HQ: Amsterdam
980 Employees
On-site Workplace

What We Do

Norgine is a leading European specialist pharmaceutical company that has been bringing transformative medicines to patients for over a century. Our commitment to transforming people’s lives drives everything we do and our European experience, fully integrated infrastructure and exceptional partnership approach enables us to quickly apply creative solutions to bring life-changing medicines to patients that they may not otherwise be able to access. Norgine is proud to have helped 24 million patients around the world in 2021 and generated €505 million in net product sales, a growth of 10% over 2020.

Norgine has a direct presence in 16 European countries, as well as Australia and New Zealand. We also have a strong global network of partnerships in non-Norgine markets. We are a flexible and fully integrated pharmaceutical business, with manufacturing (Hengoed, Wales and Dreux, France), third party supply networks and significant product development capabilities, in addition to our sales and marketing infrastructure. This enables us to acquire, develop and commercialise specialist and innovative products that make a real difference to the lives of patients around the world.

In 2012, Norgine established Norgine Ventures, a complementary business which supports innovative healthcare companies through the provision of debt-like financing in Europe and the US. For more information, please visit www.norgineventures.com.

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