Job Description
Job Description
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
Qualifications
- 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
Additional Information
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.
Company Description
SGS are the world’s leading testing, inspection and certification company SGS Group. We deliver solutions to a wide range of industry sectors in Ireland. Enjoy a truly rewarding career in a global, multicultural organisation with a proud heritage that has been making the world a better, safer place for over 140 years.
Our client services include providing SGS QC analysts and technical support staff on-site to fulfill staffing requirements (Scientific In-sourcing), all under the supervision and guidance of ISL technical and operational teams. Like all SGS personnel, they are committed to upholding stringent technical and GMP standards, ensuring the safety of medications for the multitude of patients relying on the products we test.
Due to growth, we have an exciting opportunity for an experienced QC Lead Analyst to join our growing Scientific In-sourcing team.