0000091626-Site Chg Ctrl Coordinator (6m) at Suffern

Job Description

JOB DESCRIPTION:Purpose:Change Control for all Global and US changes to marketed products and associated GxP areas. Represents QA on high level projects affecting Compliance.Responsibilities:Responsible for the Review and Approval of Change Control Requests and associated validation documents, MMFs, Testing Monographs etc.Responsible for representing QA on various projects as Compliance Officer to assure regulatory compliance.Strong Leadership Skills, able to mentor and motivate associates.Provides expertise and guidance in interpreting government regulations, agency guidelines and internal policies.Excellent knowledge of cGMPs and 21 CFR Part 11 Regulations Is imaginative, thorough and practical in providing solutions for a wide range of difficult problems.Evaluates and conducts pre-assessments of change requests to evaluate the impact of the change and determine the distribution of the change request in order to obtain advice/approval or to provide notification.Conduct continual follow-up of change requests to insure quick resolution and that all documents are provided that support the change for future inspections.Utilize all electronic on line capabilities available to process, track and follow-up on all changes. Provide expert recommendations and consultation to local and supplier sites concerning change control issues.This person interfaces with other change control staff at international and domestic sites to develop positive relationships to insure consistency with all Change Control Processes.Provides recommendations to insure continuous improvement to the process.Initiates the development of novel/complex change control strategies to insure that changes are facilitated with no adverse impact to product supply, quality and compliance.Utilizes available systems to periodically review product-impacted changes to insure the continued compliance with FDA regulations and no adverse affect to quality and supply.Provides Change Control oriented advice to technical experts supporting revisions that will insure quick retrieval of documents required during FDA & internal audits and inspections.Assists in the efforts to conduct conformance audits and inspections by the FDA to insure continuous compliance to Federal and Industry requirements surrounding product-impacted changes.Assemble and review data requested for Annual ProductReporting to the FDA for technical content.Provide supporting reports to insure that changes which impact the registration applicable to a drug product or drug substance within the country in which it is distributed are communicated to the regulatory group which is responsible for that sector.JOB REQUIREMENTS:Skills:10+ years of pharmaceutical industry experience preferred.The position also requires in-depth knowledge of industry validation practices, GMPs and regulatory requirements.Knowledge of pharmaceutical manufacturing and packaging practices is extremely desirable.Experience with Trackwise or Agile is a plusEducation Science degree or equivalent with 10+ years of pharmaceutical related experienceORL

Job Requirements

 
Country: USA, State: New York, City: Suffern, Company: InVentiv Health.