QC Bioassay Analyst

RT Lane Recruitment
R.T. Lane Recruitment are currently recruiting for a QC Bioassay Analyst to work with a Pharmaceutical Company in Carlow.
This is an 11-month contract with strong potential for extension.
**Please note that candidates must hold the correct working visa for Ireland as my client cannot offer visa assistance and must be already residing in Ireland**
** Please note due to a high volume of applicants you will only be contacted if suitable for the position. **
POSITION RESPONSIBILITIES
- Work as directed by the Bioassay Manager / Associate Director, according to Company safety policies, cGMP and cGLP.
- Required to drive compliance with our Global policies, procedures and guidelines and regulatory requirements and execute Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
- Ensure that all Quality Systems within the department are adhered to daily.
- Operate as part of the QC team performing the allocated testing and laboratory-based duties.
- Participate in the timely generation of trend data, investigations, non-conformances, validation protocols, reports in support of method validation/verifications and equipment qualifications.
- Participate in QC Tier 1 daily meetings and ensure effective communication of testing progress, deviations etc.
- Peer review testing documentation and ensuring data integrity compliance and QC Right First Time KPIs are achieved.
- Participate in internal and external audits and inspections, taking the role of auditee for assigned areas of responsibility.
- Drive continuous improvement, perform root cause analysis on system failures and substandard equipment performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc,
QUALIFICATIONS & EXPERIENCE – KNOWLEDGE AND SKILLS REQUIREMENTS
Technical
- Knowledge of regulatory/ code requirements to Irish, European and International Codes, Standards and Practices.
- Knowledge of cGMP
- Laboratory Quality Systems
- Understanding of Lean Six Sigma Methodology preferred.
- Immunoassay and cell culture experience preferable
Education
Bachelor’s Degree or higher preferred; ideally in a science related discipline.
For more information or a full Job Description please contact – Michelle Power, R.T. Lane Recruitment on 022 46969, 087 032 8195 or email michelle@rtlanerecruitment.ie
To apply for this job email your details to michelle@rtlanerecruitment.ie.