Advanced Manufacturing Technician (API) APICOM

at  AstraZeneca

ESSENTIAL SKILLS/EXPERIENCE:

• Excellent team player with problem solving skills who thrives in a collaborative team environment.
• Team player and good collaborator
• GMP and regulatory knowledge/awareness
• Applicants should be educated to a minimum of leaving certificate /relevant trade.
• Experience from API production or other pharmaceutical manufacturing
• Excellent Documentation Practices and Computer skills
• Lean awareness.
• Strong safety attitude and approach to training/workload timely completion

DESIRABLE EXPERIENCE:

• Previous start up experience
• Documentation generation (drafting initial SOPs, MBR, LIMS sampling plans etc)
• Familiar with manufacturing process systems e.g. Delta V
• Lean qualification.
• Familiar with Electronic batch records.
• Experience of investigations and CAPAs and change controls.
• Experience of Tank farm operations.
• Excellent IT skills (excel, word, powerpoint etc)
• Awareness and understanding of process equipment and TPM.

• As a member of the operations team, you’ll carry out multi-stage Active Pharmaceutical Ingredient (API) manufacturing processes in compliance with AstraZeneca, GMP & SHE standards. In addition, you will also:
• Provide operational expertise at accommodation meetings such as processing risk assessments.
• Reinforce standards required in terms of GMP, SHE and specific product requirements
• Receive, accept, locate, store, dispatch and deliver products and materials and complete all relevant documentation to meet GMP and SHE standards
• Collaborate with the relevant function to receive and return the materials/components that feed into the production process.
• Set-up routings for production, change over and cleans and maintain relevant equipment to enable the smooth running of the plant unit.
• Perform and document the results of equipment cleaning hot spot inspections
• Carry out ‘free from gross contamination’ cleaning inspections