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Testing of pharmaceutical substances raw materials and drug substances in a GMP environment in accordance with clients' procedures and quality systems. The main focus will be GC and HPLC analysis, along with a range of other analytical techniques as required.
Key Accountabilities
* Receive training from SGS and client and get trained in relevant analytical techniques.
* Train other analysts where appropriately qualified.
* Carry out testing in accordance to the valid testing procedures and regulatory requirements.
* Ensure that laboratory equipment is well maintained, and calibrations are carried out at the designated frequencies.
* Manage inventory and status of materials required for analysis.
* When qualified to do so, verify and review results generated by other analysts for compliance with requirements.
* Ensure correct data entry to LIMS.
* Assessment of testing results generated in the laboratory and close out of batch analysis.
* Ensure that all target dates are met. Update visibility tools and communicate status of testing at meetings.
* Maintain laboratories to a high housekeeping standard.
* Ensure high standard of lab records, with work completed Right First Time and on time.
* Write and maintain necessary documentation (SOPs, methods, reports etc).
* Work as part of the team ensuring customer expectations are met and exceeded. Support achievement of client and SGS Key Performance Indicators, such as around investigations, training, productivity and on-time testing.
* Notify appropriate contact and document results and investigations for any atypical or aberrant results.
* Lead Laboratory investigations and deviations if required.
* Maintenance of a safe working environment, in a state of audit readiness.
* Identification and implementation of safety, environmental, quality and service improvements.
* Work with their leader to ensure self-development and progression.
* At all times, adopt a safe behaviour by exercising due regard for the health and safety of yourself, colleagues, and clients, in line with the Company’s policies and procedures.
* Ensure full compliance with the Company’s Code of Integrity, and act in accordance with SGS Ireland’s Equality & Diversity Policy.
Qualifications
* Science Degree in Chemistry or equivalent (Level 7 minimum).
* 2 years experience in a GMP laboratory.
* Data Integrity and sound knowledge of analytical technologies (HPLC, GC, KF, IR, PSD, X-ray, Wet chemistry).
* Team player, flexible to evolving needs with a strong customer service mentality.
* Excellent quality and safety standards.
* Aptitude in lab computer systems, including LIMS and Trackwise.
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