Qc Stability Co-ordinator - Swindon, United Kingdom - Catalent

Catalent
Catalent
Verified Company
Swindon, United Kingdom

3 weeks ago

Tom O´Connor

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Tom O´Connor

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Description

Do you enjoy being in an environment that is focused around delivering meaningful work at a dynamic pace? Do you want to join a high performing team in a global pharmaceutical company that invests in its people to help them develop and progress? Our number one value is Patient First.

Everything we do surrounds this philosophy and we see our employees as our primary asset when it comes to achieving this essential business value.

The QC department in Catalent is the powerhouse of commercial release activities for final products.

The department also has a stability stream that supports ongoing stability studies whilst also playing a pivotal role in cleaning validation on the factory floor.

The Department is made up of highly motivated and positively engaged staff, ranging from technicians to scientists. The QC team has a track record of internal development and progression.

It is team where a scientist can develop their technical and people skills as part of initial and continuous training programme.

Catalent are currently recruiting for a QC Stability Co-ordinator.

The QC stability Co-ordinator will ensure all QC commitment stability studies are fulfilled and conducted in line with customer and regulatory requirements in conjunction with company procedures.


The Role:

  • To ensure all QC commitment stability studies are fulfilled and conducted in line with customer and
- regulatory requirements in conjunction with company procedures.

  • To coordinate all activities necessary for the QC Stability process from initiation of a set down, analysis of time point samples, shipping of samples if required, to activities associated with the closure of a stability study, within study timelines, as per our internal documentation.
  • To coordinate with the planners of commercial release testing and inprocess Validation analysis to ensure all stability analysis is tested and verified within specified test windows.
  • To write or review stability reports, prior to Manager approval, and provide to internal or external customers as applicable.
  • To provide regular stability process updates to the Chemistry team as required.
  • Proven ability to conduct analysis in support of Stability, QC Release and analysis in support of process validation as required by the role.
  • To perform analysis for all analytical samples using the available techniques and instrumentation in accordance with defined analytical methods and Standard Operating Procedures and within agreed customer request dates or project time lines.
  • Identification of laboratory Out of Specification or Atypical results.
  • To perform other tasks as may be required by line management.
  • Previous laboratory experience advantageous but not essential.
  • High attention to detail
  • Able to prioritize
  • Strong customer service, both written and verbal
  • Good knowledge of Microsoft packages.

Catalent offers rewarding opportunities to further your career Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve.

As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety.

The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer and does not discriminate based on any characteristic protected by local law.
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