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Assistant Manager, QA - Denville, NJ

Job Information

ID :
#38224505
# of Positions :
1
Minimum Education Level :
Master's Degree
Experience Required :
2 years
Duration :
Full Time Regular
Shift :
First Shift (Day)
Hours per week:
40

Job Description

 

Under supervision of the department head, works closely with product development teams to review and approve all the submission documents to file an application with USFDA for approval. Apply knowledge of Federal, State, FDA, and ICH guidelines to review and validate the technical CMC (Chemistry, Manufacturing and Control) documents for generic drug filing (ANDAs), amendments and supplements submission with the US FDA. Monitor impact of changing ICH, FDA guidance’s and regulations on quality, submission strategies and update internal stakeholders. Assess and approve the change controls and supervise the change management activities including verification of effectiveness of the related change. Act as liaison between organization and CMOs/Vendors/Partners in establishment of binding quality agreements and enforcement of responsibilities as outlines in the approved ANDA/NDAs. Assist manager in quality compliance and Regulatory inspections and maintain site quality compliance including establishing and maintaining SOP’s, training aspects, good documentation practices, and maintain site compliance with the FDA, DEA regulations. Manage market compliance, and investigations. Apply State rules and statutes for drug product release and distribution in USA market and oversee the distribution activities to ensure compliance. Assist in mock recall/recall activities including but not limited to drafting of Health Hazard Assessments, initial notification to FDA, classification of recall, wholesaler and patient outreach, review of distribution and reverse distribution practices/documents/product. Coordinate with the development team to decide and implement immediate corrective actions as required and applicable. Must have a Master’s degree in Pharmacy, Regulatory Affairs or Project Management (with concentration in Regulatory Affairs). Must have 2 years’ experience in the fields of Regulatory Affairs and Quality Assurance within a generic pharmaceutical environment. Must have prior experience in preparing and reviewing electronic publishing and filing various types of regulatory submissions (DMF / ANDA / NDA (505 b2) / IND including amendments, supplements, and pre-submission documentation) with USFDA. Experience in generic drug filings to the USFDA with expertise in CMC, structured product labeling, establishment registrations, Validation and eCTD publishing is required. Strong knowledge in Pharmaceutical Development of Immediate Release Tablets, Extended-Release Tablets, Transdermal Patches, Topical Aerosols (sprays), Ointments, Creams, Gels, Nasal Sprays, and Topical Solutions is required. Knowledge of Code of federal regulations (Title 21, Part 314 and applicable subparts and relevant FDA guidance’s), ICH guidelines including GLP and cGMP regulations. Strong attention to details. Must be able to prioritize assigned development of multiple projects. Demonstrate acceptable skills in oral and written communications, independent judgment, teaching and training, problem solving/decision making, adhering to timelines, negotiation skills, integrity and adaptability. 40 hours per week: 9 am-5 pm. Must have proof of legal authority to work in the United States.

Company Information

Name :
RiconPharma LLC
Description :
Founded in April 2008, RiconPharma LLC (hereinafter “RiconPharma”) is a Research & Development company, which is equipped with a 10,000 sq. ft., state of the art R & D facility located in Denville Technical Park, Denville, New Jersey. RiconPharma develops novel drug delivery systems, alternate routes of administration, product enhancement, modified release dosage forms etc., for new products and supports the life cycle management of approved pharmaceutical products. RiconPharma’s key focus areas are Pre-formulations, Formulation Development, Manufacturing Process Technologies, Analytical Testing, and Regulatory Submissions. Our core competencies are Oral Solids (IR, MR, ODT and Films), Topicals (Ointments, Creams, Lotions, Foams and Gels), Transdermals (Matrix and Reservoir Systems), Liquids (Solutions and Suspensions) and Parenterals (Loyophilization).
Type :
Direct Employer
Address :
100 Ford Road
Suite 9
Denville, NJ 07834

Application Information

Instructions :
To be considered, please send resume to Human Resources, RiconPharma LLC, at hr@ingenus.com Job Ref. # 20210443.
Email :
Job Posting Entered On :
6/16/2022
Job Posting Expires On :
7/20/2022