QC/QA Analyst-Data Review Job
QC DATA REVIEW ANALYST JOB-CHEMISTRY
*I currently have a fantastic opportunity for a QC Analyst looking to move into a QA documentation role. Flexible work hours/work from home days can be facilitated*.
If you are an experienced QC Analyst/Chemist with 3-4 years' experience in a GMP environment and looking to move away from bench testing role , then this Data Review Analyst -Chemistry Job is an excellent opportunity not to be missed .
This is an exciting chance to join an leading pharmaceutical company in Waterford that can offer you excellent opportunities for progression and development. In this Data Review Analyst job you'll be working in an amazing , modern facility with cutting edge technology and in a dynamic and supportive working environment.
*This is a permanent position with a very attractive salary package*
Duties and Responsibilities
- Check raw data and ensure all pertinent procedures (SOPs) and analytical methods have been followed when analysing products and calculating results.
- Review documentation related to analyses (lab book, reference standard preparation logbook) in regard to good documentation practices, calculation and reporting of results.
- Assess the calibration status of instruments and other tools used to perform the testing.
- Declare and document any deviation using current quality system procedures.
- Ensure compliance and quality of analysis in respect to analytical methods and current specifications for raw materials and finished products.
- Document and investigate any out-of-specification (OOS) results according to current procedure.
- Maintain an up to date OOS list, review any pending items, and close investigations on time.
- Close laboratory reports and proceed to the release of raw materials.
- Issue certificates of analysis for finished products
- Work closely with the Laboratory Supervisor to maintain timelines, inform of any deviation or OOS results that may impact delivery deadlines.
- Participate in archiving the raw data, certificates of analysis and investigation reports.
- Drive CAPA and other action item follow up.
- Bachelor's degree in Chemistry, Biochemistry or related science.
- Minimum of 3-4 years of quality control analytical chemistry in a GMP environment(essential)
- Strong knowledge and understanding of cGMP and cGLP, data integrity principles, good documentation practices and laboratory investigations.
- Knowledge of analytical techniques, Empower 3 software and general chemistry testing for pharmaceuticals
- Strong leadership, initiative, autonomy, problem solving, organisation, results-orientation, communication and interpersonal skills.
- Courage to inform about any quality event observed or any delay that impacts the established timeline.
- Familiarity with Quality Management Software i.e. Trackwise or other
Once your CV has been received, I will give you a call to speak about the role in more detail and what this Data Review Analyst job could offer you!
If you are interested in hearing more about this unique , Data Review Analyst job opportunity please contact Felicity Farrell @FRS Recruitment on or connect with me on LinkedIn
Applicants are advised to APPLY NOW to avoid disappointment.
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