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- 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 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.
- Identification and implementation of safety, environmental, quality and service improvements
- Work with their leader to ensure self-development and progression
- Science Graduate in Chemistry or equivalent education with greater than 3+ 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.).
QC analyst - Dublin, Ireland - SGS
Description
Job Description
QC Analyst for testing of pharmaceutical drug substances and reference standards in accordance with corporate procedures and in compliance with the current GMP standards.
Key Responsibilities
Qualifications