Posted Tuesday, April 2, 2024 at 4:00 AM
Kindeva Drug Delivery is on a mission to solve drug delivery challenges and change patients’ lives worldwide, and we are able to achieve this due to our innovative, collaborative team. If you want to grow your CDMO career and be a force for good, you will have everything you need to excel at Kindeva.
With over a century of experience in combination product development and manufacturing, Kindeva is truly a global force in drug delivery. We have state of the art facilities across the US and UK and our capabilities span delivery formats, from ideation through commercialisation.
At Kindeva, we manufacture more tomorrows. Our products change and save lives across the world, and we are committed to developing meaningful and powerful solutions for our partners and the patients we serve. Every member of our team contributes to this mission, making a real difference, every day.
Ready to take on a career that matters? Look no further, we are hiring for a talented QC Microbiology Lab Technologist to join our Loughborough team.
Summary of Position
This role will be responsible for the testing of pharmaceutical raw materials (including components), intermediates and finished products for batch release, stability, development studies and customer complaints in line with site procedures. Completion of site support activities including Environmental monitoring, water analysis and microbial identification analysis. The employee would represent the department as required to include external customers and regulators.
Other responsibilities are included in EPR along with other tasks that may be deemed appropriate by supervision.
Job Responsibilities
Safety
· Knowledge and application of current safety regulations (e.g., CoSHH) as applicable to laboratory functions.
GMP
· Follow the 10 rules of GMP.
· Work to appropriate laboratory systems, standards and procedures, e.g., data recording, labelling, investigation and calibration procedures. Complete analytical documentation including the input of results onto the LIMS system.
· Awareness of current regulatory standards as applicable to laboratory functions.
· Maintain good laboratory housekeeping.
· Maintain GMP / GLP standards and principles within the laboratory area.
Microbiological Testing
· Perform microbiological testing using methods where training has been received with minimal avoidable errors in order to meet scheduled timelines.
· Perform new test methods and techniques once full training has been received.
· Complete preliminary investigations and full-scale investigations.
· Review and issue GMP documentation where full training has been received.
· Provide coaching and guidance to more junior members of the team and advise on testing and validation strategies for new methods and equipment.
Product, Equipment and Process Knowledge
· Have a basic knowledge of pharmaceutical products and testing.
· Develop an understanding of the tests carried out and their impact on the products/materials worked on.
· Responsible for the maintenance and calibration of laboratory equipment.
· Support continuous improvement activities within own group.
· Participate as a team member for Group CI projects as appropriate.
Time Management
· Develop a basic understanding of the resources required to perform laboratory-based activities.
Please note that this is not an exhaustive list of responsibilities.
Skills & Experience
* Ideally have worked with GLP, GMP, Specifications and Test Methods.
* Ideally have 1 year of experience of testing within the Pharmaceutical Laboratory.
* Must have hands-on experience of aseptic techniques and ideally aseptic manufacture.
* Must have knowledge of pharmaceutical testing requirements, testing equipment and current Analytical techniques.
What we will give to you:
* Attractive compensation package.
* Company pension scheme (up to 10% employer contribution). 25 days holiday per year (plus bank holidays) plus service days after 5 years.
* Company sick pay.
* Employee Assistance Program with 24/7 confidential helpline support for employee and immediate family. Life assurance of four times life cover salary.
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