QC LEAD (CHEMISTRY) with 5+ years hands-on work experience working in laboratory to cGMP regulatory guidelines within the biopharmaceutical industry required by CareerWise Recruitment for our multinational BioTech client in Limerick.
The QC LEAD (CHEMISTRY) will perform a variety of chemical analyses on raw materials, final products, in-process materials or stability samples in support of the quality program.
Role of this position
- Gathers data and documents test results.
- Reviews test results to ensure compliance with standards; reports any quality anomalies.
- Complies with all pertinent regulatory agency requirements.
- Participates in required training activities.
- Conducts testing on raw materials, in-process, product, stability, and/or research samples.
- Writes and revises control test procedures and SOPs.
- Completes test records and reviews data.
- Calibrates or verifies calibration of instruments/devices prior to use.
- Interacts with outside customers or functional peer groups.
- May be responsible for maintaining a specific project.
- Conducts laboratory investigations and generates reports in response to invalid assays, Deviations, OOS/OOT.
- Initiates and completes CAPAs and Change Controls in accordance with site procedure
- May be required to review and approve Laboratory Investigations
- Provides on-the-floor guidance and support to employees.
- Ensures employees timesheets are completed on time.
- Monitors employees training to ensure that all requirements are met, including OJT.
- Maintain up to date training records for self and direct reports.
- Perform minimally monthly performance feedback meetings with direct reports.
- Represent area management at leadership meetings as required
- Escalates all performance issues to management and/or HR.
- A third level qualification (BSc degree or higher) in chemistry, biology or related field.
- Preferably with 5+ years hands-on work experience working in laboratory to cGMP regulatory guidelines within the biopharmaceutical industry
- Excellent Communication skills, both verbal & written.
- Experience with electronic systems such as LIMS, Empower, SoftMax, Qumas, eDoc, Trackwise etc., is an advantage.
- Adaptable and flexible, willing to work shift if required and willing to travel when needed.
- Strong analytical ability and associated problem solving.
- Good time management and attention to detail.
- Knowledge and proficient in the use of Microsoft products including, Excel, Word and Powerpoint.
Please call Conor Twomey today for further information on 021 4297422 or email: firstname.lastname@example.org
CareerWise Recruitment (In Search of Excellence)