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Job Description Summary
To provide Quality Control support during batch manufacture and filling process across the In Process lab.
Graduate Role Specific
* In Process Testing Support e.g. MET, BU etc
* Running Team DMS Board at Tier 1
* Supporting EM programme
* Consumable management
* 5S support
Roles And Responsibilities
* Providing QC support during batch manufacture, ensuring turnaround times are achieved as outlined in QC/Production Service Level Agreement and product release times.
* Including In process Chemistry/Microbiological analysis, finished product Chemistry/Microbiological analysis.
* WFI & Steam sampling and analysis
* Water collection
* Actively involved in Investigations e.g. Batch Corrections, EMI, Bioburden etc
* Performing routine instrument calibrations and calibration checks.
* Routine maintenance of equipment
* Ensuring compliance with cGMP, EHS, GxP etc guidelines at all times.
* Entering and approving results on LIMS/MODA & completion of batch documentation
* Assisting with audits and ensuring lab is inspection ready as required.
* Assisting with 5S of In Process Lab.
* Consumable management – ordering, stock take and following up with vendors on expected delivery times etc.
* Supporting logbook review and archiving for In Process.
* Ensure compliance with current pharmacopoeia and all regulatory/company guidelines.
* Interaction with other departments e.g. Production, Engineering, QA.
* Assisting in the training and up skilling of colleagues where possible.
* Liaising with internal and external customers in relation to QC/Production issues
* Any other duties as required by QC PTL and/or designee.
Principal Qualifications
A third level Science Qualification
Skills REQUIRED
Good communications skills, excellent time management skills, flexibility and agility will be required. Openness to change. Proven ability to work on own initiative and deliver expectations.
Desired Work Experience
Pharmaceutical experience in a GMP regulated laboratory environment.
Additional Information
Relocation Assistance Provided: No
Seniority level
Internship
Employment type
Full-time
Job function
Quality Assurance
Industries
Hospitals and Health Care
Location and Salary
Cork, County Cork, Ireland €65,000.00-€75,000.00
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