This position is to provide 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 and finished product Chemistry/Microbiological analysis. This is a shift role and is for a 12 month FTC.
Responsibilities:
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WFI & Steam sampling and analysis
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Performing and Managing the Environmental Monitoring programme in
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conjunction with clean room operators.
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Support of batch release through microbiological and chemical testing including; RI, pH, UV-VIS, Titrations, BET, Bioburden testing.
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Establishing best practice standards within the clean room and focusing on driving appropriate clean room behaviours.
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Actively involved in Investigations eg Batch Corrections, EMI, Bioburden etc
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Support report and protocol generation e.g. quarterly trend reports
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Performing routine instrument calibrations and calibration checks.
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Ensuring compliance with GMP, EHS, GxP etc guidelines always.
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Ensuring compliance with current pharmacopoeia and regulatory/company
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guidelines.
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Entering and approving results on LIMS/MODA & completion of batch
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documentation
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Assist with audits as required, participating in 5S audits across QC and participation in daily Tier 1 DMS.
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Be proactive in approach planning for future and implementing improvements in an effective manner.
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To develop areas of expertise in analytical testing to solve technical issues.
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Interaction with other departments e.g. Business Unit, Engineering, QA.
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Keep colleagues informed of current issues and developments as appropriate
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Liaising with internal and external customers in relation to QC/Production issues
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Reasonable level of Overtime will be required to facilitate business needs, note this is a 12 month fixed term contract.
PRINCIPAL QUALIFICATIONS
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Science Qualification and/or equivalent work experience.
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Good communications skills, teamwork skills, excellent time management skills, flexibility and agility will be required.
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Openness to change and a proven ability to work on own initiative and deliver expectations.
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Experience in SAP, LIMS, MODA is desirable.
Inclusion and Diversity
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.
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.
Total Rewards
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
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Relocation Assistance Provided: No
