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Job Description

JOB DESCRIPTION

JOB TITLE:                           Quality Assurance Student       

REPORTS TO:                                     Quality Executive 

JOB PURPOSE:

Working with the Quality team to help maintain quality standards throughout the company. The brief requires knowledge of Good Manufacturing Practice, current FDA and EMEA regulations for solid oral dosage pharmaceuticals for human use and a good working knowledge of manufacturing processes and packaging processes used in the pharmaceutical industry.

RESPONSIBILITIES:

• To assist in the investigation into non-conformances, participate in root cause analysis and carry out quality review of non-conformances
• Preparation and revision of cGMP documentation as required including;
• Annual Product Reviews
• Standard Operating Procedures
• Product specification
• Technical Reports and Protocols
• Support the site Quality Management systems including;
• Non-Conformance and CAPA Management systems
• Change Control system
• Internal Auditing programs
• GMP Training
• Customer Complaints
• Vendor Management program.
• Participate in and facilitate continuous improvement projects as required
• Control/storage of retain samples, including periodic retain inspection

GENERAL RESPONSIBILITIES:

• Participate fully in any cross functional training initiatives.
• Drive and promote the corporate values of Takeda-ism within the workplace.
• Actively foster, in cooperation with other TIL staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business.
• Ensure that Accident Reports / Near Miss Forms are completed in a timely manner after an event.

• 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.

EDUCATIONAL REQUIREMENTS: 

• Studying towards a degree in a scientific discipline or other relevant course.

RELEVANT EXPERIENCE:

• Experience in the pharmaceutical industry would be preferable but is not essential.

SKILLS/COMPETENCIES:

• Excellent verbal and written communication skills.
• Be self-motivated, flexible, organized and a good team player with the ability to prioritize own work based on departmental and site requirements.

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