DP Manufacturing technician will perform Pre and post-production activities including performing line clearances of the manufacturing areas, Aseptic filling, coding and labeling products and perform visual inspection along with other duties.
Location: Reykjavik, Iceland
Key responsibilities and work assignments:
Be able to work in accordance with GMP practices, conducting all activities in a compliant and safe manner. Performing activities above and beyond their responsibilities as and when required.
The individual will need to perform the following activities:
- Pre and post-production activities including performing line clearances of the manufacturing areas
- Cleaning and preparing areas for production, including equipment preparation using autoclaves, VPHP chamber and washers
- Weighing and compounding activities including set up of filters
- Aseptic manipulations outside the filling suites, as well as perform visual inspection on syringes and vial products
- Aseptic filling
- Coding and labelling of vial and syringe products using the dedicated equipment
- Visual inspection
- Monitoring of the environmental and building monitoring systems
- Sampling of WFI within the department
- Writing and amending departmental documentation under supervision
- To complete all batch related documentation including forms and logbooks
- Notifying line manager of identified deviations
- Education: Minimum of a BSc in pharmacy, biotechnology, biochemistry, engineering or a related field
- Experience: None as full training provided
- Should have excellent written and verbal communication skills
- Linguistic Skills: Fluent command of the English language, both written and verbal
- Computer Literacy: Proficient in use of a PC and common Microsoft packages such as Word, Visio, Excel
- Organisation and Management Skills: Will be required to participate and make positive contribution to team meetings. Responsible for individual performance management.
- GMP GDP Experience: Will be expected to work to and comply with the requirements of Alvotech QMS cGMP and GDP Practises and Policies. Will participate in self inspections and regulatory inspections.