What are the responsibilities and job description for the Supervisor, QA Inspection - 2nd Shift position at Kindeva Drug Delivery?
Our Work Matters
At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.
The Impact You Will Make
In the role of a Supervisor-Quality Assurance you will plan and coordinates the activities of the Quality Assurance colleagues to support P&I production activities. Your responsibilities include ensuring quality inspections are consistent with established standards and batch records requirements, adherence to SOP’s and GMP’s regulations. You will supervise quality employees engaged in QA activities and support P&I on identification and resolution of issues.
Role Responsibilities
Supervision/coordinationofdutiessuch as AQL sampling, line clearances, label printing, product/component segregation, product/component labeling and batch record issuance on shift
Assist P&I Supervisors in the resolution/identification of issues. Escalate critical issues to P&I and QA management.
Coordinates and/or approves changes to SOPs, specifications, and Batch Records (BRs),
Initiate ERs/QARs and Change Management as required.
Coordinatesshift personnel activities – i.e., training, vacations, sick time, etc. to ensure there is always appropriate coverage in the QA department.
Ensure QA Inspectors curriculum and training are up to date.
Maintains quality assurance objectives complementary to departmental and corporate policies and goals; develops new approaches to solve problems identified during quality assurance activities.
Basic Qualifications
Bachelor’s degree or Associate degree in technical or science discipline and two years' experience and/or training; or equivalent combination of education and experience. Supervisory experience in a pharmaceutical/combination product/medical devices manufacturing industry preferable.
Technical Skills
Experience in the pharmaceutical/combination product/medical devices/Quality Assurance environment, thorough knowledge of cGMPs, production procedures and company policies and pertinent SOPs.
TrackWise, Inventory system (SAP, PRISM)
Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e- mail and phone communications and attending multiple meetings and conference calls. Note that these activities may not be time bound to core hours or presence at the site.
Must have the ability to work effectively under and manage to strict production, time and performance deadlines.
#LI-Onsite
