Senior Associate, Quality Support
Suppo rt t he N orth America Quality for Field Alert Reports, Drug Product Recalls, and monthly Recall Reports covering all the products distributed in the US market. Support the NAM Quality Cluster in terms of liaison with multiple sites Product Quality Complaints and complaint sample management. Assists sites under North America Cluster for Compliance activities, as needed.
Management of Fiel d Alert Repots (FARs) including the submissions of all initial, follow-up, and final
FA Rs f or t he USA market. Answers related FDA queries in conjunction with the manufacturing site.
A tten ds Global Recall Committee meetings. Management of US Drug Product Recalls including all submissions to FDA. Coordinate with district office for closure of Recalls. Answers related FDA queries in conjunction with the manufacturing site. Coordinates all recall activities with third party service providers or site, as applicable. Collate recall data on monthly basis and submit report to FDA.
Ma nagement o f oth er documentation/responses to FDA such as Biological Product Deviation Reports
(B PDRs), D ru g Notifications.
Ma nagement of th ird party service provider for US Product Quality Complaints. Maintains master list for complaint samples intake and sample procurement instructions, resolves issue, and provides guidance to site regarding complaint investigations, as needed. Reviews, edits, and sends response letters to complainants for overseas facilities, as needed.
Review s investigations, provides guidance, and routinely follow-ups with sites to drive closure.
A ssign s product and packaging codes for the National Drug Code (NDC), as applicable.
L i a i s o n a nd c ommunicate with Sales & Marketing/Supply Chain, and others, as needed for US related market actions.
Support N orth Amer ica region in terms of analytics assessment of Quality Metrics and monitor
i m p l e m e n t a t i o n o f act ion items at sites for improvement of compliance level.
Support a n d c o-ordinate 483/WL Observation responses with support of Corporate Quality
C o m p li a n c e t eam in I ndia. Timely filing of response to inspection observations and commitments.
Support N o rth A merica region compliance activities, as needed.
Qualit y Assurance Office Environment located in a Manufacturing/Production, Testing and Warehouse Facility.

M a nu f a c t u r i n g / P r od u c t i o n E n v i r o n m e n t
Ware house E n v i r o n m e n t

Education and Experience:
Minimu m of BS in Chemistry, Pharmacy, Biochemistry or related field; MS/PhD preferred.
A dvanced k nowledge of FDA/regulatory authority drug regulations and guidance.
D emo nstrated abil ity to support regulatory and customer audits to successful outcomes.
A dvanced k nowledge of regulatory requirements related to pharmaceutical manufacturing and 21
CFR r eq u i r e m e n t s .
A s elf-starter with a hands-on approach and a can-do attitude.
A team b uilding champion driving innovative cross functional synergies.
Strong p roject management, organizational and problem solving skills.
E x t e n s i v e u n de r s t a n d i n g of p olicies, guidelines and systems related to quality assurance programs, cGLP and cGMP audits.
A bilit y to collate and present data for regional quality metrics/management review.
Strong n egotiation skills, relational skills and ability to communicate effectively with all levels of the organization and external stakeholders.
Th e requirement for English language proficiency for this job role is Intermediate-B1+ (comparable
to Global CE FR Independent B1) level based on the Common European Framework of Reference for
L a n g u a Client s ( C E F R ) .
Minimu m of ten (10) years of experience in the regulated pharmaceutical industry within the Quality
A ssurance an d/or Quality Control environment.
E x pe r i e n c e w ith cr eation of Field Alert Repots (FARs) including initial submissions, follow-up, and final
FA Rs.
E x pe r i e n c e wi th conducting US Drug Product Recalls including all submissions to FDA and coordinating all recall activities with third party service providers and site, as applicable.
E x pe r i e n c e i n c ommunicating with, and responding to FDA queries.
E x pe r i e n c e c o n d u c t i n g Tec hnical Reviews and Writing (includes but is not limited to the following: Investigations, Protocols, Test Methods, Standard Operating Procedures, Corporate Policies, Global Quality Standards, Quality Agreements, Confidentiality Disclosure Agreements, Change Controls, Deviations, Investigations, CAPA's, Responses to Regulatory Agency Observations, FAR/Recall Support).
E x pe r i e n c e s u ppo r t i n g i n v e s t i g a t i o n s and c onclusions with strong compliance decisions regarding
produ ct d i s po s i t i o n .

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