11 days old

Manager Quality Assurance / Chef, Assurance Qualite

Pfizer
Brandon, NY 12966
Apply Now
Apply on the Company Site
Posting closing date: April 3, 2020

Date de fin d'affichage: Le 3 avril 2020



Status: Regular, Full Time

Statut: Rgulier, Temps plein



(Franais suivre)



QA manager leads the Quality Assurance team to assure that all activities related to process, testing, and disposition of pharmaceutical product are completed as per schedule and in full compliance with cGMP and applicable regulations.



The ideal candidate possesses the following qualifications:



+ Minimum Bachelor of Science and >10 years' experience within the Quality department within the pharmaceutical industry

+ Effective leadership, project management and interpersonal skill

+ Require excellent written and verbal skills





Key duties include:



+ Approving manufacturing and laboratory investigations, including closure of associated corrective/preventative action commitments

+ Approving validation protocols and final reports

+ Approving risk management reports

+ Ensuring timely review of batch records and analytical results to provide independent and timely disposition of pharmaceutical product

+ Managing staff to ensure workload is organized for efficient completion and in compliance with regulations and Pfizer policies

+ Leads sustainable regulatory excellence by maintaining and continually improving systems and supporting documents to ensure a favorable site regulatory profile

+ Identifies and reports adverse events and product complaints as per Corporate procedure, including Your Reporting Responsibilities (YRR) training.



__________________________________________________________

**Chef, Assurance Qualit**

Le responsable AQ dirige l'quipe d'Assurance Qualit pour s'assurer que toutes les activits lies au processus de manufacture, aux tests et la disposition des produits pharmaceutiques sont effectues conformment au planning et en pleine conformit avec les BFP et les rglementations applicables.



Le candidat idal possde les qualifications suivantes:



+ Le minimum requis est un Baccalaurat en Sciences et >10 d'exprience dans un dpartement de Qualit au sein de l'industrie pharmaceutique

+ Leadership efficace, gestion de projet et comptences interpersonnelles

+ Excellentes comptences crites et verbales sont requises





Les fonctions cls comprennent:



+ Approuver les enqutes de manufacture et de laboratoire, y compris la clture des engagements de mesures correctives/prventives associes.

+ Approuver les protocoles de validation et les rapports finaux.

+ Approuver les rapports de gestion des risques.

+ Assurer un examen en temps opportune des dossiers de lots et des rsultats analytiques pour permettre une disposition temps des produits pharmaceutiques

+ Gestion du personnel pour assurer que la charge de travail est organise pour une excution efficace et en conformit avec les rglementations et les politiques Pfizer.

+ Diriger l'excellence rglementaire durable en maintenant et en amliorant continuellement les systmes et les documents justificatifs pour assurer un profit

+ Veiller la reconnaissance et la dclaration des manifestations indsirables et des plaintes relatives aux produits, conformment aux normes de l'entreprise, dont la formation intitule Responsabilits en matire de pharmacovigilance.





Grade/Niveau: 7A



Pfizer encourages women, Aboriginal people, persons with disabilities and members of visible minorities to apply. Pfizer will accommodate the needs of applicants with disabilities throughout all stages of the selection process. Should accommodation during the recruitment process be required, please advise your Talent Acquisition representative.



Pfizer est un employeur qui invite les femmes, les Autochtones, les personnes handicapes ainsi que les membres des minorits visibles soumettre leur candidature. Pfizer s'adaptera aux besoins des candidats handicaps pour chaque tape du processus de slection. Si des mesures d'adaptation sont ncessaires pendant le processus de recrutement, veuillez en aviser votre reprsentant du recrutement.



**\#LI-PFE**



Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.



Quality Assurance and Control
Posted: 2020-03-23 Expires: 2020-04-23

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Manager Quality Assurance / Chef, Assurance Qualite

Pfizer
Brandon, NY 12966

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast