Darbo aprašymas

Tasks

To prepare the documents related to the incorporation of new equipment in the plant (URS's, equipment cards, equipment labels, manuals, qualification protocols, change controls, risk analysis...).

 Follow up of the industrialization batches, data collection for the completion of the industrialization protocols.

Preparation of documentation to ensure compliance with GMP.

 Feeding the SAP plant management system.

Evaluate technical process information and prepare process flow sheets and scaling documentation necessary for the determination of transfer and scaling needs to the different plant departments (equipment, facilities).

 Write reports of risk analysis sessions and HAZOP's.

Reikalavimai

Key skills

• Organisational capacity.
• Motivation and ability to transmit motivation.
• Leadership skills.
• Ability to work as part of a team.
• Ability to work under pressure.
• Ability to multi-task.

BASIC ACADEMIC EDUCATION

Degree in Biology, Biochemistry, Pharmacy or Chemistry

SPECIFIC TRAINING

PhD or Master's degree in Biotechnology.

WORK EXPERIENCE

Experience in GMP plants.

Experience in technology transfer.

Experience in performing risk analysis and HAZOP's of process and facilities.

Experience in validation of analytical methods, preferably in the biotechnology / biopharmaceutical industry.

Experience in managing the incorporation of new equipment in chemical plants.

LANGUAGES

High English level: C1