Gem Partnership Ltd
General overview:
To define and perform the specific tasks required to calibrate, maintain, repair and install equipment, and to provide hands on support to maintain and improve the reliability of equipment.
Previous pharmaceutical experience would be a distinct advantage.
- Hours of work: 37 per week, this is 8:30am – 5:00pm Monday to Thursday, 8:30am – 4:30pm on a Friday with an hour unpaid lunch break per day
- Pension: If the employee contributes 5% of their annual salary into the pension scheme, the company will contribute 10%. The pension is through Aviva and comes with other discounts such as car, travel and health insurance.
- Permanent Health insurance
- Holidays: 28 days paid holiday per leave year plus Public Bank Holidays. The holiday year runs from 1 January to 31 December (closing during the week of Christmas).
- Accident and life insurance: The company has a personal accident and life insurance scheme for all employees which is three times your annual salary.
Key Responsibilities:
•To maintain consistent and documented compliance with all relevant Safety, Health and Environmental (SHE), Good Manufacturing Practice (GMP), Data Integrity (DI), quality and best practice requirements.
• To carry out routine maintenance tasks in line with agreed schedule, recording all results in the appropriate system and reporting back on any anomalies.
• Working within GMP areas and guidelines.
• To respond in a timely fashion to breakdown conditions and work in such a way as to minimise downtime.
• To provide maintenance cover throughout the working day and, at times, during out of hours working (extended days and weekends).
• To ensure that spare parts required for the maintenance activities are controlled and ordered in a timescale appropriate to maintaining the toolset uptime. Comply with the internal and external regulatory environment such as procurement, maintaining records, traceability, and confidentiality.
• To ensure all relevant personnel are kept informed of progress or proposed changes on their own maintenance operations so as to minimise the impact on the processes being operated on that particular tool.
• To be responsible for their own continuous professional development. Gradually put into practice skills and competencies learned both on and off the job and to share professional knowledge with colleagues.
• To identify and understand the requirements of internal and external customers and use creative thinking and problem solving to challenge assumptions, innovate, make new proposals, and build on existing ideas.
• To contribute to the development of specific technical projects and have a working knowledge of project management procedures; set up, planning and the execution.
• To report results within agreed timescales with the support of colleagues.
• To contribute to a culture of continuous performance improvement within the technical environment in alignment with company strategy and project deliverables.
• To work in a safe and efficient manner with due regard to the SHE rules and policies on the site and be responsible for general housekeeping for the area they are working within.
Good Manufacturing Practice – GMP
The business has a responsibility to manufacture medicinal products of the requisite quality, fit for their intended use and be in accordance with the relevant Manufacturing and Marketing Authorisations, Clinical Trial Authorisation, Product Specification, Drug Master File or CEP Dossier as appropriate and which do not place patients at risk due to inadequate safety, quality or efficacy. The Pharmaceutical Quality System, which incorporates Good Manufacturing Practice, is designed to deliver this quality objective, the attainment of which requires the participation and commitment of all staff across departments and at all levels within the company. Good Manufacturing Practice is the part of Quality Management which ensures that products are consistently produced to the correct quality standards. To comply with the principles of GMP, it is required that clearly defined procedures are adhered to when performing operations across the business.
Data Integrity – DI Data Integrity is the degree to which data are complete, consistent, accurate, trustworthy, reliable and that these characteristics of the data are maintained throughout the data life cycle. The data should be collected and maintained in a secure manner, so that they are attributable, legible, contemporaneously recorded, original (or a true copy) and accurate. Assuring data integrity requires appropriate quality and risk management systems, including adherence to sound scientific principles and good documentation practices.
As a GXP organisation, they have developed a Pharmaceutical Quality System, which incorporates a DI Governance System – a series of arrangements to ensure that data, irrespective of the format in which they are generated, are recorded, processed, retained and used to ensure the record throughout the data lifecycle. To comply with the principles of DI, it is required that clearly defined procedures are adhered to when performing operations across the site.
Person specification
Education / Qualifications:
Essential:
Educated to HNC level (or equivalent) in a technical subject.
Desirable:
Educated to HND level (or equivalent) in a technical subject.
Being able to discuss their work across a number of functional areas to ensure the end users are aware of the maintenance/repair work being completed and thus infer the impact on their operations.
This vacancy is being advertised on behalf of GEM Partnership Ltd, who are operating as an Employment Agency.
To apply for this job please visit uk.whatjobs.com.