QC Laboratory Apprentice

JOB TITLE:                          QC Laboratory Apprentice

REPORTS TO:                     QC Team Leader

JOB PURPOSE: 

This brief demands a commitment to the quality effort, i.e., the application of sound practices and good technical skills.

PERSONAL QUALITIES:

The QC Apprentice will be trained to possess the following skills:

• Demonstrate the ability to operate equipment and instruments effectively and according to standard operating procedures (SOPs).

• Demonstrate the ability to work effectively in a safe manner within the laboratory.

• Demonstratethe theoretical knowledge of relevant sciences and technology.

• Handle materials and equipment correctly paying due regard to safety and environmental protection regulations.

• Capability to perform basic chemistry techniques to include but not limited to the use of:

Pipettes, Auto-Titrators, pH, Weighing, Diluting to Volume, Volumetric Calculations, Karl Fischer, Thin Layer Chromatography and Physical Testing.

• Ability to identify and note equipment (foe sampling, testing and control) malfunction if it occurs, and informing the QC Team Leader.

RESPONSIBILITIES: 

• Understand the fundamentals of Science.

• Understand the principles of cGMP.

• Understand the quality systems that are in place and their importance.

• Ability to work safely in the laboratory, maintaining excellent housekeeping whilst following appropriate safety, environment and risk management systems.

• Understanding of basic chemistry and microbiological techniques.

• Knowledge of pharmacopeias.

• Understand safe laboratory and safe work practices and methods.

• Knowledge of methods of receiving and logging samples into a QC laboratory.

• Knowledge of the variety of methods involved in water testing, raw material, in-process and finished product.

• Understanding the importance of data integrity, recording results in a timely and accurate manner.

• Understanding the correct labelling of laboratory reagents and samples.

• Knowledge of “out of specification” investigations and laboratory investigation processes.

• Knowledge of the purchase systems of QC consumables and liaising with approved suppliers.

• Understanding the various steps in the production processes – upstream and downstream.

• Knowledge of calibrating laboratory equipment as required.

• Knowledge of reporting processes and current deficiencies in GLP/GMP.

• Ensure that Accident Reports / Near Miss Forms are completed in a timely manner after an event.

• Participate fully in any cross functional training initiatives.

• Drive and promote the corporate values of Takeda-ism within the workplace.

• Ensure timely completion of all SOP, reading, training and assessment.

• Other duties as required and directed by the relevant Manager or other Officer appointed by the Board of Directors

SOFT SKILLS:  

• Communicate effectively using a full range of skills:

• Speaking, listening, listening, writing, body language, presentation.

• Work and interact effectively within a team.

• Good technical writing skills.

• Work independently and take responsibility for initiating and completing tasks.

• Understand impact of work on others, especially where related to diversity and equality.

• Time management and ability to complete work to schedule.

• Ability to handle change and respond to change management processes.

EDUCATIONAL REQUIREMENTS:   

For entry into year 1 of Level 6 QC Apprenticeship Programme:

• Pass (Grade O6 or better) in five Leaving Certificate subjects, one of which must be maths and one science related subject.

• 250 CAO points.

Or

• Relevant FETAC Level 5 or Level 6 Graduate.

• Current employee with relevant experience and qualifications.

RELEVANT EXPERIENCE: 

Administration experience desirable with a good understanding of general Administrative Skills.

CORE COMPETENCIES/BEHAVIOURS: 

• Health, Safety and Environmental awareness.

• Ability to share knowledge and expertise with others.

• Engage in teamwork.

• Complete integrity and compliance programmes.

• Ability to work independently.

• Reading comprehension.

• Problem solving.

• Critical thinking.

• Time management.

• Microsoft Office (Word/Excel).

• Mathematics and statistics.

• Continuous professional development.