Job Description Summary
To ensure all analysis is performed in a timely, compliant and efficient manner so as to meet logistical needs.
Job Description
MAIN DUTIES AND RESPONSIBILITIES
Sampling and analysis of materials (excipients, glass vials, caps, stoppers and USB components, packaging material)
Retaining of samples for Chemistry and Packaging.
Updating the Retain Database as required
Actively involved in Investigations e.g. MQI’s, Vendor Complaints, LIR’s., MERTS and Trackwise items etc..
Work with SAP for an optimal use of the system.
Entering results on SAP, checking results are within specification and also task approval.
Ensure compliance with EHS at all times, actively participate in EHS activities.
Perform routine instrument calibration checks at appropriate times.
Preparation and control of Standard Operating Procedures and ensuring compliance with cGMP guidelines at all times.
Completion of Documentation for Batch Release process.
Assisting in the provision of trends
Support the Internal Audit Process..
Generation/ reporting of Key performance indicators for the group.
Be proactive in approach planning for future and implement improvements in an effective manner.
Develop areas of expertise in analytical testing in order to solve technical issues.
Ensure compliance with current pharmacopoeias and all regulatory/company guidelines.
Interaction with other department’s e.g. BU, Engineering, QA, Validation etc..
Keep colleagues informed of current issues and developments as appropriate.
Assist in the training and up skilling of colleagues.
Reasonable level of overtime will be required to facilitate the business needs.
Liaising with internal and external customers e.g., planning/ QA/ Validation etc.
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
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