- Ringaskiddy, Cork, Ireland
SGS is the world's leading Inspection, Verification, Testing and Certification company. We are recognised as the global benchmark for quality and integrity. With more than 89,000 employees, we operate a network of more than 2,600 offices and laboratories around the world. We deliver global service with local expertise, to market leading clients across 10 different industries worldwide.
SGS ISL require an experienced QC Analyst for testing of pharmaceutical drug substances and reference standards in accordance with corporate procedures and in compliance with the current GMP standards.
- Carry out testing of drug substances in accordance to the valid testing procedures and regulatory requirements
- Ensure that laboratory equipment are well maintained and calibrations are carried out at the designated frequencies.
- Review results generated by other analysts for compliance with requirements.
- Ensure correct data entry to LIMS.
- Ensure that all target dates are met. Communicate status of testing at Tier 1 Unit meetings.
- Maintain laboratories to a high housekeeping standard.
- Carry out method transfers and participate in the validation of analytical test methods as required.
- Write and maintain necessary documentation (test protocols, SOPs, instrumentation manuals and checkout sheets, method transfer reports,) according to the existing SOPs and cGMP standards.
- Lead Laboratory investigations and deviations if required.
- Assessment of testing results generated in the laboratory and close out of batch analysis.
- Maintain a safe working environment, in a state of audit readiness.
- Maintain own state of the art knowledge of cGMPs and relevant analytical techniques.
- Science Graduate in Chemistry or equivalent education with greater than 1 years experience.
- Experience with current Good Manufacturing Practices (GMP) and sound knowledge of analytical technologies with demonstrated troubleshooting skills.
- Previous hands on experience in a regulated laboratory within the Pharmaceutical industry would be an advantage (HPLC, GC, UV, PSD, XRPD, wet chemistry, dissolution, etc.).
- Integrity, consistency and flexibility
- Professionalism; how you conduct yourself with the client, contractors and colleagues at all times
- Strong analytical ability and associated problem solving
- Organisational skills and computer literate
- Good time management & attention to detail
- Results and performance driven
- Compliance with SGS policies and procedures
- Participate in team meetings / Team player/ Self directed
- Excellent communication skills both verbal & written