Quality , Science, Pharmaceutical & Food

QC Chemistry Team Lead

  • Full Time
  • Remote
  • Limerick
  • 41831245

Summary
Performs a variety of chemical analyses on raw materials, final products, in-process materials, or stability samples in support of the companys quality program.

Essential Duties and Responsibilities include, but are not limited to, the following

• 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.

• Maintains laboratory supplies.

• 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.

• May devise or develop new analytical methods and techniques.

• May assist in validation of methods.

• May be involved in establishing the transfer of methodology from R&D.

• 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

• Maybe required to review and approve Laboratory Investigations

• Act as area SME for Internal and External Inspections

Lead-Related Activities include, but are not limited to, the following

• 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.

Education and Experience

• 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.

Collaboration and team work. Maintains the highest standards of ethical behaviour.

• Results and performance driven.

• 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.

Preferred Laboratory Experience in one or more of the following areas

• Analytical
o HPLC
o UPLC
o UV-Vis spectrophotometry
o Densitometry
o Wet chemistry testing techniques including pH, conductivity, appearance and osmolality.

For more info please contact Sean on 0214297900 or email your CV to Sean.Barron@peglobal.net

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