Stability Associate QC
CK Group is recruiting for a Stability Associate QC to join a company in the Pharmaceutical industry at their site based in Dun Laoghaire on a 12 month contract basis.
This role pays €30-34.61 per hour Ltd depending on experience.
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: Under minimal supervision, responsible for one or more of the following activities in QC including sample and data management and equipment maintenance. Contributes to the team by ensuring the quality of all tasks/services provided by self. Contributes to the completion of milestones associated with specific projects or activities within team.
This role will support QC, NPI and manufacturing operations, as such some extended hours, out of hours and weekend work flexibility may be necessary as required.
- Support Stability Programme on site and frequent collaboration with global Stability Product Representatives (SPR) or Product Quality Leads (PQL) regarding all stability programme matters.
- Perform routine sample management tasks as per procedures.
- With a high degree of technical flexibility, work across diverse areas within QC.
- Plan and perform multiple, complex routine/non-routine methods and procedures and a large variety of tasks.
- Troubleshoot, solve problems and communicate with stakeholders.
- Initiate and/or implement changes in controlled documents.
- Participate in audits, initiatives, and projects that may be departmental or organizational in scope.
- Introduce new techniques/processes to the area, where appropriate.
- Evaluate sample management practices for compliance and operational excellence improvement on a continuous basis.
- May provide technical guidance. May contribute to regulatory filings.
- May represent the department/organization on various teams.
- May interact with outside resources.
- Perform general housekeeping in all sample management areas.
- Support all NPI activities with QC.
- Understanding and application of principles, concepts, theories and standards of GMP QC analytical laboratories. Deepens technical knowledge through exposure and continuous learning.
- Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery.
- Bachelor's degree in a Science related field is required.
- Biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical industry.
- Would be advantageous if the candidate has a minimum of 2 years of specific sample management/stability Programme management experience.
- Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
For more information or to apply for this position, please contact Lucy Stendall on 01246 457725 or email firstname.lastname@example.org. 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 46276 in all correspondence.