Testing of pharmaceutical substances e.g. raw materials and drug substances in a GMP environment in accordance with clients' procedures and quality systems. 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 qualified in relevant analytical techniques. Maintain own training 100% current. 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
- Education and training: Science Graduate in Chemistry or equivalent science education (Level 7)
- Necessary job experience: At least 2 years' experience in a GMP laboratory. GMP experience is a minimum requirement for this position.
- Professional requirements: Demonstrated Experience with current Good Manufacturing Practices, Data Integrity and sound knowledge of analytical technologies (HPLC, GC, KF, IR, PSD, Xray, Wet chemistry)
- Good organizational skills and strong communication – written and verbal
- 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
Expected Behaviors:
- Integrity, flexibility, working under own initiative
- Strong analytical ability and associated problem solving
- Results and performance driven
- Good time management & attention to detail
- Professionalism; with the client, contractors and colleagues at all times
- Compliance with SGS and client policies and procedures
To apply please submit your CV.
Candidates must be immediately eligible to work in Ireland, this is a site based role.
We are an equal opportunity employer and value diversity at our company.