Quality Records Specialist CMC - Dun Laoghaire, Ireland
CK Group is recruiting for a Quality Records Specialist to join a company in the Pharmaceutical industry at their site based in Dun Laoghaire on a 12 month contract basis, with a salary of up to €51 per hour.
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.
Provide information insight and data analysis, drive execution of transactional/tactical tasks to ensure Company Contract Manufacturing (ACM) work cell (hub) success.
Manufacturing Operations: Ensure accuracy and completion of data entries and/or tasks for budget development, monitoring, and reporting; inputs to contracts, confidentiality disclosure agreement(s), scope of work agreement(s), request for pricing/information, supply agreement(s) etc. Own NC Class II/III records, CAPA, CAPA EV, and more complex change control records.
Site Performance Monitoring: Report contract site performance metrics to site lead; identify improvement opportunities for site performance; daily duties will include coordination, issuance, and review of meeting minutes, conclusions from analysis of data and metrics, continuous improvement and standardization of performance tools used by the Work Center Teams (WCT), oversight and reporting of procurement/payment of invoices, and active participation in WCT meetings with the contract site as well as internal site team.
Project Management and Technology Transfers: Follow-up and track activities in a department-wide project from conception to implementation and close-out. Manage timeline and highlight risks of transfer team activities; coordinate risk management activities as part of transfer; provide escalation to the right level.
Candidate will be working with teams in Italy and Germany and in the US, so ideally need some flexibility with working hours.
- Bachelor's in Business Administration, Engineering or Science-related field.
- Strong experience in API, DS, DP or packaging manufacturing environment (Preference is Drug Product).
- Strong knowledge in roles requiring knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles.
- Project management experience leading multi-functional and/or multi-location team.
- Experience working with external parties and/or leading cross-functional teams for clinical and/or commercial products.
- Previous work experience in Quality, Inspection and Packaging would be beneficial.
Change control and deviation experience is essential.
For more information or to apply for this position, please contact Julie on 01438 723500 or email email@example.com. 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 46063 in all correspondence.