QC Analyst - Micro

Cpl Group; Leinster; Presencial; EUR 42.000 - 52.000; Jornada completa

Descripción de la vacante

Pfizer is seeking a QC Analyst Micro to join our team on an 11-month fixed-term contract at the state-of-the-art Dublin Grange Castle plant. This is an onsite role.

The successful candidate will perform microbiological testing on finished drug products, in-process materials, stability samples and environmental monitoring, calibrate instruments, document results, and support audits and investigations. Training of others and ensuring cGMP compliance are also expected.

Formación

• Third level Qualification in Science, Engineering or equivalent is preferred though not essential. Exceptions may be considered where relevant skills/experience and correct attitude and behaviors exist.
• Excellent communication and interpersonal skills
• This job description indicates the general nature and level of work expected of the incumbent. It is not designed to cover or contain a comprehensive listing of all activities, duties or responsibilities required of the incumbent. Incumbents may be asked to perform other duties as required

Responsabilidades

• Perform Microbiological testing analysis on finished drug product, in process materials, stability samples and environmental monitoring.
• Calibration and use of laboratory instrumentation.
• Complete documentation associated with analytical results in a timely manner.
• Report and document any non-conformances to the QC Manager.
• Assist in the preparation and review of area documentation e.g. SOPs, Reports, Protocols.
• Assist in the training of other analysts.
• Ensure training compliance within assigned work area and QC.
• Perform and assist in additional duties as directed by the QC Manager.
• Ensure relevant assays are performed on samples in support of release test and stability test programs.
• Support validation and qualification of test methods and processes.
• Facilitate laboratory investigations and support associated product investigation.
• Support Laboratory inspection and audits.
• Troubleshoot laboratory methods and instrument problems.
• Establish and monitor trend analysis program.
• Contribute to the operations of the Quality Control Laboratories.
• Liaise with all customers both internal and external.
• Record and review laboratory testing documentation to cGMP standard.
• Implement and adhere to appropriate levels of cGMP within the laboratory.
• Promote safety awareness and the established culture of IIF within the assigned work area.
• Ensure that sample analysis is conducted to meet batch disposition requirements.

Conocimientos

Communication skills

Educación

Science/Engineering degree

Descripción del empleo

Cpl In partnership with our client Pfizer are seeking a QC Analyst Micro to join the team for an 11 month fixed term contract, Onsite at their state of the art plant in Dublin, Grange Castle. this is an Onsite role.

Job Responsibilities:

• Perform Microbiological testing analysis on, but not limited to, finished drug product, in process materials, stability samples and environmental monitoring.
• Responsible for calibration and use of laboratory instrumentation.
• Complete documentation associated with analytical results in a timely manner.
• Report and document any non-conformances to the QC Manager.
• Assist in the preparation and review of area documentation e.g. SOP's, Reports, Protocols.
• Assist in the training of other analysts.
• Ensure training compliance within assigned work area and QC.
• Perform and assist in additional duties as directed by the QC Manager.
• Ensure relevant assays are performed on samples in support of release test and stability test programs.
• Support any validation and qualification of test methods and processes.
• Facilitate laboratory investigations and support associated product investigation.
• Support Laboratory inspection and audits.
• Troubleshoot laboratory methods and instrument problems.
• Establish and monitor trend analysis program.
• Contribute to the operations of the Quality Control Laboratories.
• Liaise with all customers both internal and external.
• Record and review laboratory testing documentation to cGMP standard.
• Implement and adhere to appropriate levels of cGMP within the laboratory.
• Promote safety awareness and the established culture of IIF within the assigned work area.
• Ensure that sample analysis is conducted to meet batch disposition requirements.

To be successful in this role the following are prerequisites to application:

• Third level Qualification in Science, Engineering or equivalent is preferred though not essential. Exceptions may be considered where relevant skills/experience and correct attitude and behaviors exist (this may be supplemented by further education in parallel)
• Excellent communication and interpersonal skills
• This job description indicates the general nature and level of work expected of the incumbent. It is not designed to cover or contain a comprehensive listing of all activities, duties or responsibilities required of the incumbent. Incumbents may be asked to perform other duties as required