JOB DESCRIPTION SUMMARY

To provide Quality Control support during batch manufacture and filling process across the In Process lab.

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.

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.