Posted: 14h ago
The role
Job Description Summary
To provide Quality Control support during batch manufacture and filling process.
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
Performing and Managing the Environmental Monitoring programme in conjunction with clean room operators.
Support of batch release through isolation and identification of microorganisms and further analysis including Heatshock testing and Growth Promotion testing.
Establishing best practice standards within the clean room and focusing on driving appropriate clean room behaviours.
Actively involved in Investigations e.g. Batch Corrections, EMI, Bioburden etc.
Actively involved in report and protocol generation e.g. Quarterly trend reports.
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.
Assist with audits as required.
Generation/Reporting of key performance indicators for the group.
Be proactive in approach planning for future and implementing improvements in effective manner.
To develop areas of expertise in analytical testing in order to solve technical issues.
Planning and resourcing for plant specific projects that require QC services.
Ensure compliance with current pharmacopoeia and all regulatory/company guidelines.
Interaction with other departments e.g. Production, Engineering, QA.
Keep colleagues informed of current issues and developments as appropriate.
Assist in the training and up skilling of colleagues.
Liaising with internal and external customers in relation to QC/Production issues.
Reasonable level of overtime will be required to facilitate business needs.
Qualifications
Science Qualification and equivalent lab experience.
Good communications skills, excellent time management skills, flexibility and agility will be required.
Openness to change.
Proven ability to work on own initiative.
Pharmaceutical experience in a GMP regulated laboratory environment.
Equal Opportunity Employment
GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
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