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 validation and 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 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