Posted Thursday, February 8, 2024 at 5:00 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 Global Quality Systems Specialist to join our Loughborough team.
Role overview
Role is responsible for supporting the QMS within Kindeva, this is both the tool (MasterControl) and the background QMS processes, ensuring its effective use within global processes.
What would be your role and responsibilities?
* Improvement/development of QMS processes both inside and outside of MasterControl by leading and influencing those working with.
* Collaborate with team and across sites to ensure best practices are applied consistently across the organization in relation to the QMS.
* Responsible for providing/understanding of key metrics and developing reporting for identified QMS area to ensure health of QMS and identify improvements.
* Provide training/awareness to sites as required for QMS activities.
* Engage and support end users with day to day queries to resolve problems and identify further improvements.
* Maintain QMS tool in validated state by participation in issue resolution, patches and software upgrades.
* Participate in Customer/Regulatory audits as needed.
To be successful in this role we are looking for you to have:
* Degree level or equivalent in Business, Supply Chain, Engineering or Science based.
* Minimum of three years experience within a quality role in a pharmaceutical, medical device or similar regulated industry.
* Good knowledge of GMP, Quality System requirements, international regulations & standards.
* Good verbal & written communication skills, across all levels.
* Ability to cope with changing priorities, strong organizational skills and ability to work by self or in a team.
Additional information:
* All applicants must be eligible to work in the UK.
* Hours: Onsite M-F with flexible time offered.
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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