Advanced Quality Engineer

Kindeva Drug Delivery
Kindeva is a leading global contract developer and manufacturer (CDMO) with delivery platform expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies. We partner with our customers to improve patient outcomes around the world. Together, as One Team, we will manufacture many more tomorrows.
ROLE SUMMARY
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.
ROLE RESPONSIBILITIES

• Improvement/development of QMS processes both inside and outside of MasterControl by 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
• Management of user accounts within the system
• Participate in Customer/Regulatory audits as needed

BASIC QUALIFICATIONS

• Minimum of three years experience within pharmaceutical companies.
• Good knowledge of GMP, Quality System requirements, international regulations & standards.
• Good verbal & written communication skills, across all levels. Effective in decision making & influencing people.
• Ability to cope with changing priorities, strong organizational skills and ability to work by self or in teams

California residents should review our Notice for California Employees and Applicants before applying.
Covid-19:
Safety for our employees and our communities is a key priority for Kindeva Drug Delivery. Kindeva encourages everyone who can get vaccinated to get vaccinated.
Our Covid-19 task force monitors the external environment and will continue to evaluate our policies and procedures.
Equal Opportunity Employer:
Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.