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.

Additional Information