Job Description Summary
To provide Quality Control support during batch manufacture and filling process across the In Process lab.
Job Description
MAIN RESPONSIBILITIES
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.
* This includes 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