To ensure all analysis is performed in a timely, compliant and efficient manner so as to meet logistical needs.
MAIN DUTIES AND RESPONSIBILITIES:
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Sampling and analysis of materials (excipients, glass vials, caps, stoppers and USB components, packaging material)
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Retaining of samples for Chemistry and Packaging.
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Updating the Retain Database as required
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Actively involved in Investigations e.g. MQI’s, Vendor Complaints, LIR’s., MERTS and Trackwise items etc..
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Work with SAP for an optimal use of the system.
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Entering results on SAP, checking results are within specification and also task approval.
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Ensure compliance with EHS at all times, actively participate in EHS activities.
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Perform routine instrument calibration checks at appropriate times.
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Preparation and control of Standard Operating Procedures and ensuring compliance with cGMP guidelines at all times.
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Completion of Documentation for Batch Release process.
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Assisting in the provision of trends
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Support the Internal Audit Process..
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Generation/ reporting of Key performance indicators for the group.
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Be proactive in approach planning for future and implement improvements in an effective manner.
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Develop areas of expertise in analytical testing in order to solve technical issues.
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Ensure compliance with current pharmacopoeias and all regulatory/company guidelines.
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Interaction with other department’s e.g. BU, Engineering, QA, Validation etc..
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Keep colleagues informed of current issues and developments as appropriate.
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Assist in the training and up skilling of colleagues.
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Reasonable level of overtime will be required to facilitate the business needs.
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Liaising with internal and external customers e.g., planning/ QA/ Validation etc.
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Carry out additional duties as deemed necessary by your Group Leader/ Supervisor.
PRINCIPAL QUALIFICATIONS REQUIRED:
A third level science qualification and/or third level qualification
SKILLS REQUIRED:
Good communication skills, Flexibility and agility. Openness to change and a proven ability to work on own initiative.
Relocation Assistance Provided: No
