To maintain regulatory compliance through established programs for laboratory testing, maintenance, training, and SOPs within Quality Control.
• Perform real-time PCR analysis on Drug Substance and finished Drug Product.
• Responsible for calibration, maintenance, and use of laboratory instrumentation.
• Complete documentation associated with analytical results in a timely manner.
• Report and document any non-conformances to the QC Supervisor.
• 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 any additional duties as directed by the QC Supervisor.
• Ensure relevant assays are performed on samples in support of release test programs
• Support any validation and qualification of test methods and processes
• Support any equipment validation activities.
• Facilitate laboratory investigations and support associated product investigation
• Support Laboratory inspection and audits
• Troubleshoot laboratory methods and instrument problems.
• Support trend analysis programmes.
• 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.
• Assist in the implementation and maintenance of lean programmes such as 5s, standard work.
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
People / Values
• Demonstrate the GC OWNIT values
• Adhere to all HR Policies as appropriate
• Personal Development plans focusing on the 70:20:10 guidelines
• CI tools/- capability is a key building block for learning & development - Trained and M1 certified.
• Proactive engagement with key stakeholders.
• Best practices developed and shared with other teams /sites.
• Best practices actively sought and copied.
• Proactive & effective communication within and across shifts
Interested applicants should apply with CV.