QC Analyst 12 Month FTC
ExternalFull-timeOn-site1w ago
ComplianceDocumentation
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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
Requirements
- 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.
- Inclusion and Diversity
- Behaviors
- We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership - always with unyielding integrity.
Benefits
#LI-MG1Additional InformationRelocation Assistance Provided: NoHealth insurance
Additional Information
Job Description Summary To provide Quality Control support during batch manufacture and filling process. GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world Job Description
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