Senior GMP Coordinator
Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we save precious time and money in getting drugs to patients.
As a growing and successful business, we employ more than 1,100 talented individuals globally, located at state-of-the-art development, manufacturing and clinical facilities in the UK and USA.
Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we do in the way that we do it. People join Quotient Sciences because we are a respected member of the drug development community, driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.
Responsible for maintenance of the GMP area, Equipment and related activities.
To comply & adhere to Good Manufacturing Practice (GMP) standards.
Main tasks and responsibilities will include:
- Coordination and oversight of routine GMP area cleaning activities / documentation as per established GMP procedures.
- Generate necessary work orders and coordinate any repair, maintenance and/or calibration activities with the facilities and engineering group.
- Author and/or review Standard Operating Procedures
- Work closely with formulation and manufacturing personnel to facilitate batch completion
- Review of GMP area logbooks to ensure compliance.
- Work closely with QA to ensure that timely release of rooms and equipment
- Maintain spare parts inventory.
- Serve as SME for the area during audit tours.
- Ensure quality and training of the group.
- Author and/or review quality investigations pertaining to the GMP area to ensure timely completion and proper implementation of CAPAs with help of department leadership to ensure compliance.
- Participate in departmental meetings and contributes towards any improvement initiatives.
- Good familiarity with the GMP regulations and Good Documentation Practices.
- Good knowledge of solids production equipment and processes.
- Skilled in troubleshooting of equipment and facility.
- Computer skills:
- Enter data into computer using software applications for data entry and word processing.
- Work and be proficient with e-mail systems
- Ability to perform under stress in cases of emergency, critical or hazardous situations.
- Ability to work with others in a team environment.
The job may involve the following:
- Very high concentration of work
- Strict and tight deadlines
- Having to juggle a range of tasks/issues simultaneously
- Working in a hazardous environment with high requirement to follow safety procedures
- Working outside normal working hours
- Needing to respond to client demands
- High School Diploma or higher with minimum of 5-7 year of industry experience especially in GMP manufacturing set up.
- Read, write and interpret documents such as safety rules, operating and maintenance instructions, and standard operating procedure manuals.
- Fill out necessary forms, write short reports and business correspondences.
- Work with basic mathematical operations.
- Apply concepts such as fractions, percentages, ratios and proportions to practical solutions.
- Define problems, collect data, establish facts and draw valid conclusions.
In return you will receive a competitive salary, a generous benefits package, excellent training and development, as well as an exciting career within a fast paced and dynamic business.