Quality Assurance Manager

Overview

Quality Assurance Manager (Florham Park NJ) Analyze and oversee quality assurance of pharmaceutical product including quality control practice CMC (Chemistry Manufacturing and Control) and process in all stages of the drug manufacturing testing packaging and documentation and FDA drug approval submissions to ensure product quality standards and FDA / ANDA regulatory compliance; Identify mitigate and resolve regulatory compliance and quality issues that may affect drug products; Perform batch records review and communicate any adverse findings to approved Contract Manufacturing Organizations (CMO); Perform product quality investigations and participate in the assessment of each investigation; Review investigation reports and complete the timely closure of all batch record review findings prior to product release; Resolve quality issues and product complaints including investigations deviations OOS / OOT investigations CAPAs change controls and quality complains related to manufacturing packaging; Implement CAPAs and assess CAPA effectiveness; Review and approve stability protocols and stability results;Review and Approve Validation (process cleaning method) protocols and reports Author and review Annual Product ReviewDraft and negotiate Quality and Technical Agreements; Provide support during regulatory inspections and audits including Labeling development; Implement and maintain quality systems including change control vendor qualification programs internal and external audits SOPs and process improvement.

Responsibilities

Must have a Masters Degree in Chemistry Pharmaceutics or Drug Regulatory Affairs plus 1 year experience in job offered. Require skills and knowledge in Change ControlValidation Audits Investigation / CAPA CMC SOP / ANDA batch records.

Job location : Florham Park NJ. Standard benefits with $141190.00$144k / year. Submit résumé referencing job code MIS007 to HR Shionogi Inc. 400 Campus Drive Florham Park NJ 07932.

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EEO

Shionogi Inc. is an equal opportunity employer supporting individuals with disabilities and veterans. All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race color religion sex (including pregnancy) marital status national origin age ancestry citizenship disability genetic information status as a disabled veteran a recently separated veteran Active Duty Wartime or Campaign Badge Veterans and Armed Forces Service Medal Veterans or any other characteristic protected by applicable law. It is the policy of Shionogi Inc. to undertake affirmative action for protected veterans and individuals with disabilities in compliance with all federal state and local requirements to recruit a diverse pool of protected veteran and individuals with disabilities applicants and to ensure that our employment practices are in fact non-discriminatory.

If you are qualified individual with a disability or a disabled veteran you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request accommodations by calling or by sending an email to

Required Experience :

Manager

Key Skills

Quality Assurance,FDA Regulations,Food Industry,Food Safety Experience,ISO 9001,Quality Systems,Food Processing,Quality Control,Quality Management,QA / QC,Selenium,HACCP

Employment Type : Full-Time

Experience : years

Vacancy : 1