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Client:
JobContax
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Job Category:
Other
EU work permit required:
Yes
Job Reference:
bfbb958e0b0d
Job Views:
75
Posted:
03.03.2025
Expiry Date:
17.04.2025
Job Description:
Employment Type: Contract
Experience: 3+ years
Visa: EU passport or Stamp 4 visa required
Our client is a leading international Biotechnology company with a state of the art aseptic manufacturing facility in Dun Laoighaire, South Dublin.
The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.
This is an excellent opportunity to get experience into Ireland's leading aseptic manufacturing plant.
Under minimal supervision, responsible for one or more of the following activities in QC including analytical testing, characterization, sample and data management:
1. QC Representative for NPI activities and routine Product meetings
2. Assist with activities related to QC projects and/or QC tasks within Site projects
3. Plan and perform non-core testing related to NPI activities
4. Manage all sample management activities related to NPI activities throughout the site
5. Create/own and approve protocols, sample plans, SOP and documentation related to NPI
6. QC Representative responsible for Method Validation and Transfers co-ordination and readiness
7. Responsible for their own training and safety compliance
8. Sample shipments and temperature monitoring activities for NPI activities
9. LIMS data coordination of non-core (NPI) activities
10. Contributes to team by ensuring the quality of the tasks/services provided by self
11. Contributes to the completion of milestones associated with specific projects or activities within team
12. This role will support QC and manufacturing operations, as such some extended hours and weekend work flexibility may be necessary as required
13. With a high degree of technical flexibility, work across diverse areas within QC
14. Plan and perform analyses with great efficiency and accuracy
15. Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays
16. Report, evaluate, back-up/archive, trend and approve analytical data
17. Troubleshoot, solve problems and communicate with stakeholders
18. Initiate and/or implement changes in controlled documents
19. May train others as necessary
20. Participate in audits, initiatives and projects that may be departmental or organizational in scope
21. Write protocols and perform assay validation and equipment qualification/ verification
22. Introduce new techniques to the lab, including method transfers, reports, validations and protocols
23. May contribute to regulatory filings
24. May conduct lab investigations as necessary
25. Evaluate lab practices for compliance on a continuous basis
26. May represent the department/organization on various teams
27. May interact with outside resources
28. Create APPX data files and randomisation memo to facilitate data analysis
29. LIMS data coordination of commercial and import testing on site where applicable
30. May provide technical guidance
Requirements:
1. 2-3 years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry
2. Strong background in Chemistry and Analytical testing is required
3. Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products
4. Understanding and application of principles, concepts, theories, and standards of GMP QC analytical laboratories
5. Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery
6. Applies analytical skills to evaluate and interpret complex situations/ problems using multiple sources of information
7. Communication skills (verbal and written) at all levels
8. Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls)
9. Demonstrated ability to work independently and deliver right first-time results
10. Working knowledge of aseptic compliance within the manufacturing environment and demonstrated leadership and communication skills to communicate requirements to colleagues
11. Auditing documentation and operation process
Package:
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