What are the responsibilities and job description for the Quality Systems Manager position at Artech LLC?
Title : Quality Systems Manager
Location : Exton PA
Duration : 12 Months
Pay rate : $71.42 / hr
This position is responsible for maintaining and improving Quality Systems for the client Americas Region to ensure on-going compliance to applicable compendia, GMP’s, and Regulatory guidance.
The Quality Systems include quality risk management, documentation, global and local auditing, health authority inspection management, training, event management (deviations, complaints, CAPA), and change control (global and local).
The role will interface with Quality System personnel in other client sites.
The person in this position will serve as a subject matter expert (SME) for GMP and Data Integrity (DI) requirements. Must effectively work as a team with internal customers, peers, and management through effective oral and written communication. Must evaluate the compliance of records, documents, and Quality Systems to ensure that the site is operating per GMP and Data Integrity requirements.
Essential Functions
Collaborate and provide expert reviews to ensure records, documents, and Quality Systems meet GMP and DI requirements (promote quality, DI, and GMP awareness).
Support external and internal audits for the
Americas sites.
Contribute to the oversight of Quality Systems core responsibilities (track, report, adjust) by trending quality metrics for
Americas sites.
Develop and manage processes that ensure the Exton site remains in compliance with global quality polices, regulatory requirements, and industry requirements, including periodic review and consolidation.
Other duties as assigned to facilitate ongoing Quality activities as required, including collaboration with other Quality groups.
Education and Experience
Bachelor’s degree (preferably in science related discipline) preferred
5 – 7 years of experience working with Quality Systems (Deviation, Change Control, CAPA, audit, etc.)
Demonstrated proficiency and experience in working with Quality Systems IT applications
Training within a regulated Pharmaceutical / biotech / medical device environment
Understanding and application of CGMP’s (EU, JP, US)
Detailed knowledge and application with electronic Quality Systems (i.e. TrackWise, Documentum)
Technical
Strong attention to detail as demonstrated through consistent quality of work
Excellent written and verbal communication skills
Computer proficiency in MS Word and Excel, Project and Visio required;
Demonstrates process orientation—thinks through required steps and sequencing to ensure quality work output
Strong project management skills are preferred
Ability to anticipate potential problems and take proactive action to avoid / minimize impact
Anticipates consequences of actions and how they impact other areas
Ability to independently prioritize, plan and schedule workflow
Timely follow up to ensure satisfactory resolution to issues
Knowledge of CGMPs (relevant laws, guidance, directives and industry practice), and demonstrated ability to apply learnings appropriately
Ability to interpret and apply GMPs, relevant laws, guidance’s and directives to extremely complex pharmaceutical situations
Ability to work and coordinate activities across multiple functional groups with a sense of professionalism and urgency
Ability to work collaboratively with internal and external team members and customers / contacts
Self-motivated; able to work with minimal supervision. Exercises independent judgment in evaluating compliance.
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