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Base pay range
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Job Title: Production Operator
Department: Production
Reports to: Quality Control, Planning, Engineering, Quality Assurance, Warehouse, Procurement
Location: Romford
Job Level: 6
Job Purpose
To work as part of a team that produce high quality pharmaceutical products with a focus on the treatment of pain, addiction and critical care.
Main Responsibilities & Duties
* As part of a team, work towards daily targets to meet the weekly production schedule utilising specialist pharmaceutical equipment.
* Ensure that all activities within the area are undertaken to established standards of Good Manufacturing Practice (cGMP).
* Complete batch manufacturing records accurately, neatly and maintaining integrity of data recorded at all times.
* Follow GMP working instructions and guidelines to ensure the product is produced to the right quality.
* Work closely with the Engineering team in the event of machine breakdowns.
* Work closely together as a team to ensure batch-to-batch tasks are completed efficiently to minimise downtime.
* Perform quality control checks throughout the process to ensure product and patient safety.
* Undertake gowning process to enter the cleanroom safely and to GMP Regulations.
* Prepare the area & sanitise equipment for use in the production of sterile or aseptic products.
* Maintain the cleanroom environment by following strict guidelines and SOP's.
* Combine pharmaceutical ingredients together to make a bulk solution ready for filling.
* Using high-tech machinery, fill the bulk solution into syringes or ampoules ready for sterilisation.
* Depending on product type, sterilise the product using specialist equipment (autoclave).
* Under the guidance of the Microbiology team, undertake environmental monitoring tasks on a routine basis.
Additional Responsibilities
* Where GxP data is generated, ensure that the principles of Data Integrity are adhered to.
* Be an active team member on continuous improvement projects bringing about improvements in working practices to eliminate waste and reduce variation in the area.
* Work with line management to perform various risk assessments within the production area to ensure a safe working environment is maintained for all staff.
* Actively support management in self-Inspections, action planning and follow-up.
* Work with the management team during investigations into batch losses to come up with solutions and improvements to prevent reoccurrences.
* Report any deviations to your process so Management can ensure batch integrity at the earliest possible opportunity.
* Assist in the development of self and peers.
* For more experienced Operators, deputise for Shift Supervisor if necessary.
* Represent the department in meetings where required.
Requirements
Educational Level
* Educated to GCSE (or equivalent) level.
Experience
* Experience of working within a process driven/structured environment.
* Experience of Microsoft packages (Word, Excel, Outlook).
* Experience of operating machinery.
* Experience working in a pharmaceutical manufacturing environment.
* Experience of using SAP.
Qualifications
* Grade A-C (or equivalent) GCSE in Maths and English.
* GCSE A-C (or equivalent) in Science or Engineering.
Knowledge
* Knowledge of health and safety standards required in a production environment.
* A good understanding of manual handling practices.
* Good knowledge of written and spoken English.
* Good understanding of cGMP within a manufacturing environment.
Skills & Personal Qualities
* Strong numeracy and literacy skills.
* High attention to detail.
* Good level of computer literacy.
* Able to follow written and oral instructions.
* Able to perform manual handling within HSE guidelines.
* Methodical approach.
* Self-starter and approachable.
* Flexible and diligent.
* Hardworking and positive attitude.
* Team player.
* Adaptable and willing to learn.
* Able to wear restrictive PPE for long periods of time.
* Technically minded, able to see beyond a process.
Seniority level
Entry level
Employment type
Full-time
Job function
Production
Industries
Pharmaceutical Manufacturing
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