Job description
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Responsible for
- performing primary and secondary operations in a GMP environment, executing operations following instructions on the approved packaging batch records in accordance with cGMPs and safety regulations
- completing required GMP documentation to ensure records of equipment used and packaging activities performed are maintained contemporaneously in applicable documentation
- adhering to SOPs, GMP, and all safety requirements involving handling and movement of clinical trial materials
- using complex software in the current approved inventory system to scan material and perform tasks required for packaging operations
- managing routine daily, weekly, monthly, and quarterly maintenance and cleaning of the rooms and equipment in the GMP packaging areas
- participating in required meetings as necessary for business updates
- identifying common equipment/process failures and troubleshoot solutions for operational challenges
- Maintain continuous workflow to follow and adhere to production schedules and timelines
- Adherence to regulations and rules such as necessary gowning requirements to gain entry and perform daily operations in the packaging areas are required. Regular gowning requirements include lab coat, disposable hat, face mask, gloves, shoe coverings, safety glasses/goggles
- No make-up, nail polish, and/or jewellery may be worn in the packaging areas where daily operations are performed
- The role requires standing for sustained periods of time as well as walking, pushing, pulling, and lifting of equipment and/or materials weighing up to a maximum of 20 kg.
- Continuous mental and visual attention, and manual dexterity to perform packaging and labeling functions is required
- 5 GCSE’s (grade C/4 and above) including Maths and English.
- Comprehension of Good Manufacturing Processes (GMP), experience preferred
- demonstrable relevant experience in a similar role preferred
- Excellent documentation skills and attention to detail
- Computer literacy in Microsoft Word
- Strong computer, scientific, and organizational skills
- Application of computer software to procure packaging documentation and facilitate packaging operations
- Excellent communication (oral and written) and attention to detail
- Ability to work independently and as part of a team, self-motivated, adaptability, and a positive attitude
- Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
Work Location Assignment: On Premise (Sandwich, Kent)