We are seeking a highly motivated and experienced Equipment Qualification Technician to join our team at our Manchester Site.
As the Equipment Qualification Technician, you will be responsible for ensuring that all analytical instrumentation is qualified according to internal and external requirements.
• Knowledge of all stages of qualification of new systems and the instrument lifecycle within our facility in a compliant manner.
• Ensure that instrument documentation to cover qualification activities i.e., URS, Validation Plan, SOP etc is produced in a timely and compliant manner.
• Work to Qualification schedules provided.
• Ensure that all documentation meets best practice.
• You will liaise with others inside and outside of the team in a proactive and reactive manner in order to provide or obtain information and to keep people informed so that work is completed effectively.
Required skills and experience:
• Strong IT literacy and numeracy skills.
• Communication skills with the ability to clearly convey processes and key messages.
• Good working knowledge of Chemical and Pharmaceutical Industry, especially with respect to system qualification process.
• Understanding of requirements for ensuring regulatory compliance in a GMP/GLP/GCP environment.
• The ability to effectively time manage their personal workload and work on multiple projects as required.
• Good comprehension skills with the ability to interpret current regulatory requirements and highlight deficiencies if they are present.
• Ability to switch focus between projects to ensure prioritised targets can be met.
Preferred skills and experience:
• Knowledge and application of appropriate systems and procedures relevant to Asset Qualification and Validation, including USP 1058, GAMP and Data Integrity (knowledge of FDA, EMA and MHRA requirements) would be beneficial.
• Previous experience of working with a pharmaceutical environment would be highly advantageous
• Knowledge and application of safety procedures, regulatory standards and general laboratory practices.
• Internal Client Focused.
If you are a proactive and motivated individual with a passion for ensuring regulatory compliance, we encourage you to apply.