JOB DESCRIPTION

Post Details
Job Title: / Technician
Generic Job Title: / Production Technician
Grade: / 5
Department/Directorate: / Production
Accountable to: / Process Leader
Main Job Purpose
The main duties include the technical aspects of machine set-up and operation and completion of associated documentation. Actively support process improvements and assist in some process and personnel supervisory activities.
The post operates within strict environmentally controlled areas and therefore
requires high levels of good hygiene practice, strict adherence to cGMP and
associated documentation.

Production Director

Sterile Operations Manager
Shift Manager
Process Leader
Technician
Production Operative
Key Duties and Responsibilities
To set up and operate automated and semi-automated equipment in compliance with approved procedures and in accordance with agreed production programmes.
To ensure that equipment used is in compliance with any maintenance, calibration and validation requirements.
To help co-ordinate the activities of the section, liaise with other sections as necessary, and help organise the daily work operations as required.
To assist with on the job training in order to perform the designated tasks.
To assist in the review and revision of SOP’s, BPR’s and related documentation.
To inform the Supervisor/Manager of issues related to H&S standards within manufacturing, and issues that could impact the quality of the manufacturing environment with regards to compliance.
To ensure that regular cleaning and maintenance is carried out on all equipment and fabric within the section in accordance with the appropriate schedules.
To adhere to GMP and H&S standards, including hygiene, environmental control and safe working practices.
To manufacture high quality, high value products, right first time, in accordance with the production programme.
To ensuredocumentationis completed accurately and at the time.
To meet departmental and section objectives fulfilling the principles of continuous improvement.
From time to time undertake other duties to meet business objectives.
Acceptance and Review
Accepted
Manager...... Date......
Jobholder...... Date......
Reviewed
Manager...... Date......
Jobholder...... Date......

Appendix

Specific Requirements for Aseptic Filling Area Operatives

Understand GMP requirements and its application in the Aseptic Filling Area (AFS)

High levels of personal hygiene are a prerequisite. Achieve the standards required to work in the Grade A filling area on an on-going routine basis. Routine participation in microbial monitoring including gowning validation, exit monitoring etc. with the on-going requirement to remain qualified in aseptic techniques, gowning practice, broth fills and the core trainingmodules.

The confidence to challenge poor practice by others working in the Aseptic Filling Suite.to achieve best practice by all.

Understand the principles of what we have to achieve in the AFS in terms of steam sterilisation, dry heat sterilisation, depyrogenation and filtration. The ability to run and understand technical equipment and perform equipment set ups is required. Able to understand and trouble shoot technical issues whilst applying the principles of GMP. Working in the area requires high levels of self-reliance and initiative.

The maintenance of the area requires undertaking physically demanding work in a GMP compliant manner, for example setting up equipment and cleaning the Aseptic Filling Suite.

Adhere to GMP requirements whilst working in an environment that has strict multi-layered gowning requirements with no exposed skin.

Have the correct attitude for working in the area. Be able to moderate behaviour over the course of an entire shift to work in a slow deliberate manner in an environment which has the minimum numbers of staff present for the job.Behaviour of a serious nature is required in the Aseptic Filling Suite.

Take part in smoke pattern testing and other exercises including validation as required to keep the AFS in operational mode.

Willingness to learn skills across the department

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