MAIN PURPOSE OF ROLE:
The purpose of the Process Operator is to produce batches of high-quality pharmaceutical products within the hand relabelling line, TransAct Pouch Line and Blister Clean Room.

The process brings together the raw ingredient all the way through to a finished pack and included control measures, Standard Operating Procedures and quality checks during the production cycle.

KEY RESPONSIBILITIES:
• To follow GMP and GDP procedures at all times.
• To work with the Commercial department to ensure knowledge of incoming deliveries.
• To operate production machinery safely and efficiently.
• To assist with the setting/checking of production machinery for production.
• To understand the importance of following procedures during the production process. To record information and data during production phases accurately
• To complete all batch paperwork correctly
• To work safely and report any Health and Safety issues to the Production Manager.
• To query any deviations from SOP’s, GMP and GDP with the Production Manager.
• To work with the Production Manager and quality department to ensure that production is started in a timely manner and all required checks are complete and logged on the appropriate paperwork.
• To understand the importance of FMD, carrying out reference sample checks.
• Maintain an up to date knowledge of the latest production work systems/ procedures.
• To understand the importance of maintaining accurate data during the Goods In process and to correctly receiving deliveries.
• To complete stock transactions using the companies SAGE computer system.
• To carry out any ad hoc/other duties as required.

KEY ACCOUNTABILITIES:
• To perform in process checks to ensure that machines work optimally during the production phases.
• To control start up and shut down duties of the machinery and production environment.
• To observe machinery to ensure conformance to quality and set standards.
• To report any problems or deviations in packaging procedures on an immediate basis to ensure that incorrect packaging does not take place.
• To prepare associated packaging documentation according to provided SOPs.
• To check packaged product to ensure that they are boxed and labelled correctly.
• To complete batch reconciliation accurately at the end of production and follow the correct batch recording procedures.
• To ensure tasks set are completed accurately and in a timely manner.
• To always follow GMP, GDP and SOP’s to ensure that work is completed correctly first time, every time and safely.
• To ensure the correct PPE is worn.
• To print variable data on to labels for batch paperwork’s.
• To print leaflets for batch paperwork’s.
• To perform line clearances and carry out batch sign in’s.

PERFORMANCE STANDARDS:
• Show commitment to good housekeeping.
• Demonstrate flexibility and willingness to assist.
• Look for ways to continually improve current work activity.
• To be punctual, polite and courteous to others at all times.
• To adhere to the Company’s policy and procedures at all times.
• Ensure clear, accurate and concise record keeping
• Demonstrate commitment, enthusiasm and passion

Qualifications
• Grade A-D in Maths and English
• Manual Handling Certificate

Experience & Competences
• Previous experience working with GMP.
• Experience completing batch paperwork, clearly and correctly.
• Previous experience working on a production line.
• Capable of working to deadlines and remain calm under pressure.

Knowledge & Skills
• Good communication, both written and oral
• Good working knowledge of Good Distribution Practice, Current Good Manufacturing Practice, Standard • • Operating Procedures, and Health and Safety Regulations
• Excellent attention to detail
• Ability to work on own initiative
• IT literate in Microsoft Software Packages, particularly Word, Excel and Outlook

Personal Qualities
• Enthusiastic and highly motivated
• Positive attitude and flexible approach to work
• Self-starting and able to work on own initiative
• Reliable and punctual
• Team player

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