Job Description SummaryTo 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
What We Do
Every day millions of people feel the impact of our intelligent devices, advanced analytics and artificial intelligence.
As a leading global medical technology and digital solutions innovator, GE Healthcare enables clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications and services, supported by its Edison intelligence platform.
With over 100 years of healthcare industry experience and around 50,000 employees globally, the company operates at the center of an ecosystem working toward precision health, digitizing healthcare, helping drive productivity and improve outcomes for patients, providers, health systems and researchers around the world.
We embrace a culture of respect, transparency, integrity and diversity.
