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Qualification specialist

Job Description

Primary Purpose of Position:

To implement the qualification process to deliver and maintain qualified Facilities, Utilities and Equipment compliant with current Standard Operating Procedures.

Specifics of Position:

·         The job holder is expected to demonstrate a willingness to engage in self-directed learning, an ability to assimilate new information into their routine working practices and a desire to develop their level of experience and expertise with the aim of progressing towards a more senior role.

·         A natural tendency towards continuous improvement is required, as it is an expectation that the Commissioning & Qualification process will evolve both to assure best practices and to maximise the efficiency of site resources. Opportunities to improve Commissioning & Qualification practices across sight should be identified.

·         Application of risk assessment tools in determining qualification effort is required.

·         The job holder is expected to develop an appreciation of regulatory expectations with respect to equipment qualification, and computerised system life-cycle requirements.

         The job holder will provide technical support for projects and routine activities associated with facilities, utilities and equipment at Technical Operations, Wrexham.

·         The job holder needs to be competent in the generation and review of technical documentation to ensure an appropriate standard, suitable for supporting regulatory inspection. Documentation will include but not be limited to commissioning and qualification documentation.

·         The ability to demonstrate an increasing understanding of qualification (including Computerised Systems Validation) requirements is necessary.

·         The role will require liaison with the site Validation/Qualification Teams to ensure that best practices are shared, with a common approach across site wherever possible. 

Operational Excellence Competency:

Operational Excellence: Incorporate operational excellence into normal ways of working. Demonstrate understanding of Lean Six Sigma principles and commitment to successful implementation of projects using Lean Six Sigma methodology.

Please select the appropriate level for the job position.

Environment, Health and Safety Compliance:

You are responsible for familiarizing yourself with the Company Environment, Health and Safety policies and procedures and ensuring that all rules and regulations are followed within your areas of work to ensure a safe working environment.

You must highlight with your line manager any difficulties or misunderstanding or deficiencies in any Standard Operating Procedure(s) Work plans etc that may give rise to a work place risk.

You must ensure that all hazards, incidents and accidents are reported to your line manager and liaise with your departmental Environment, Health and Safety Rep and Environment, Health and Safety department to improve environmental and health and safety matters within your work areas.

GMP Compliance:

To play an operational and integral part in site processes; Unplanned Events and other Investigations (Out of Specification/Complaints), Corrective/Preventive Actions, Change Control, and Internal Auditing, as required, ensuring that the processes within the Quality System sub-systems are compliant and operationally effective. To support site improvements including Quality systems improvements.

Main Duties to be Performed:

·         Support Commissioning & Qualification activities to ensure delivery in line with the (re)qualification schedule, and compliance with Standard Operating Procedure(s).

·         Continuous improvement of the Commissioning & Qualification process to eliminate waste and improve effectiveness, whilst ensuring alignment with industry best practices (e.g. ISPE initiatives) and stakeholder requirements.

·         Highlight risks to product quality throughout the Commissioning & Qualification lifecycle so that they are understood, transparent and can be managed through the application of a Quality Risk Management philosophy.

·         Oversee internal and external (contract) resource as required to ensure the compliant implementation of new systems to project requirements, and maintain plant compliance by delivering requalification to the schedule defined by the Validation Master Plan.

·         Oversee equipment vendors as required to ensure that requisite standards are adhered to.

·         Work as part of a multi-disciplined and cross functional team to meet business objectives.

·         Ensure Good Engineering Practices are adhered to throughout the Commissioning & Qualification process.

·         Specific ownership of specific systems/processes as defined by IPAP/Line Manager