Manager Quality Assurance - Cincinnati, OHDate: Mar 27, 2024Location:Cincinnati, United States, Ohio, 00000Company: Teva PharmaceuticalsJob Id: 54943Who we areTogether, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.The opportunityThis position is responsible for the facilitation and management of operational Quality Assurance functions, which includes batch record issuance, batch record review, product disposition, shop floor support, raw material release, calibration and maintenance record review and approval, in-process inspections, and other operational quality requirements. Additional responsibilities include effectively executing compliance audits of product/component documentation, issuance of appropriate status to components and product, participation in investigations, trending of quality issues as appropriate, and supporting data collection and department reporting activities to support both the GMP and regulatory requirements of the product.
Responsible for the daily management and development of direct and indirect reports supporting quality operations and shop floor resolution of issues, including participation in deviation reports
Responsible for coordinating and participating in the development, implementation and maintenance of quality assurance systems to ensure compliance with FDA regulations.
Responsible for managing all information necessary to include investigations for the proper decisions on approval or rejection of all components, drug product containers, in-process materials, packaging materials, labeling and drug products manufactured.
Responsible for the review and approval of standard operating procedures, master production records and EAM system management.
Responsible for management of retain inventory throughout the specified retention period for all commercial products.
Responsible for developing, implementing and maintaining training plan and curriculum to assure compliance with applicable regulatory requirements.
Responsible for compliance to in-house specifications/standards and Good Manufacturing Practices including maintaining related documentation (eg acceptance specifications, test methods, batch records) and ensuring the company stays current of new developments related to Good Manufacturing Practices and the quality functions.
Responsible for the review of production processes and records to assure quality; analyze trends.
Responsible for completing all training requirements and maintaining 100% compliance with all assignments.
Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), Standard Operating Procedures(SOP’s) and Batch Record instructions.
Your experience and qualificationsRequired:
Requires Bachelor’s Degree, preferably in a scientific or engineering discipline, or equivalent relevant experience
Minimum of 5 years relevant progressive experience in the pharmaceutical manufacturing or related industry
Minimum of 3 years supervisory or management experience required, preferably in manufacturing or related industry
Experience with and knowledge of regulations and practices within a heavily regulated industry, pharmaceutical, medical device or related industry preferred
Preferred:
Strong audit experience
Strong documentation assessment experience
Experience with regulatory inspections
Understanding of internal auditing processes
Computer proficiency with comprehensive working knowledge of MS Office products, Learning Management Systems (LMS), ERP systems such as SAP or Oracle and manufacturing/quality systems such as LIMS and TrackWise.
Enjoy a more rewarding choiceWe offer a competitive benefits package, including Medical, Dental, Vision, and Prescription coverage starting on the first day. We also offer Disability and Life Insurance, Paid Time Off, 13 paid Holidays, 6% match on the 401(k), Employee Stock Purchase Plan, and Tuition Assistance.Already Working @TEVA?If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply:Internal Career Site (https://performancemanager.successfactors.eu/sf/careers/jobsearch?bpltecompany=1080030P)The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.Teva’s Equal Employment Opportunity CommitmentTeva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.Important notice to Employment Agencies - Please Read CarefullyTeva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.EOE including disability/veteran