Stability Specialist

  • Salary: Up to €53.65
  • REF Number: 00047484
  • Consultant: Natasha Young
  • Contact: 01246 457739
  • Date Published: 22.01.2020
  • Closed Date: 12.02.2020
  • Sector: Pharmaceutical
  • Location: Dun Laoghaire, Ireland (Dublin area)
  • Discipline: Qa/Validation

CK Group is recruiting for a Stability Specialist to join a company in the Pharmaceutical industry at their site based in Dun Laoghaire on a 12 month contract basis and has an hourly rate of up €53.65.

The Company:

Our client is one of the worlds leading manufacturers of biosimilar and biopharmaceutical products used in the treatment of a wide range of human healthcare conditions from cancer to arthritis. This company are a strong believer in helping patients by developing new treatments and taking them to market via their global network of specialist aseptic manufacturing, packaging and distribution sites.

The Location:

This role is located on a state of the art manufacturing facility based in Dun Laoghaire and is a quick 30 minute drive away from the centre of Dublin, or 60 minutes drive from Dublin Airport. The site is easily commutable from Kildare or Wicklow by car and there is a good public transport network if you would prefer to live within Dublin itself. Dun Laoghaire is a vibrant cultural hub in south Dublin which is best known for its maritime history and locally caught sea food.

The Role:

As a Stability Specialist you will provide support to the Product Quality (PQ) organization as a subject matter expert of clinical and commercial product stability studies and GMP data management. In this team-based role, you will directly add to the success of a Product Quality Team by collaborating with diverse functional areas including Supply Chain, Manufacturing, Quality Control, Regulatory, Quality Assurance, Quality Engineering, International Quality and Process Development on projects, issue resolution and investigations.

The Stability Specialist builds and monitors stability studies within quality systems (e.g. LIMS), owns and handles product quality and stability data and may serve as a primary author on regulatory filings and directly participate in and support site-based GMP inspections. Additional responsibilities include business process support, such as SOP authoring and management, or gap assessments to regional regulations. Expertise in project management, time management and successfully navigation skills for matrixed team environments are essential.

Key Responsibilities:

  • Build and maintain technical GMP documents and product stability studies
  • Review, verify, report, and archive GMP data for clinical and commercial products
  • Apply keen attention to detail to conduct data review and reports
  • Execute transactions in relevant GMP computer-based systems (change control, LIMS, etc.)
  • Adeptly manage time-sensitive activities independently

Your Background:

To succeed in this role you will have extensive experience working in a pharmaceutical or biotech company within a Quality function. You will have excellent knowledge of biologic and synthetic pharmaceutical bulk and drug product manufacturing and analytical techniques and General knowledge of cGMP and US and international filing regulations pertaining to the manufacture and testing of pharmaceuticals and/or bio-pharmaceutical.

For more information or to apply for this position, please contact Natasha Young on +44 1246 457739 or email irishcontracts@ckagroup.co.uk. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 47484 in all correspondence.

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