GMP Quality Assurance Group Leader

Saint Paul, United States

WuXi AppTec

Posted on: June 24, 2020

Closing: July 24, 2020

Salary: 70,000 – 99,999

Position Type: Full Time

Job Description

Overview
The QA Group Leader for GMP is responsible for ensuring current Good Manufacturing Practices (cGMP) testing and GMP manufacturing activities are executed in accordance with the appropriate regulatory bodies, internal procedures and continuing improvement of Quality systems.

Responsibilities

Essential Job Functions:
  • Review and approve Certificates of Analysis, test methods, specifications, protocols and reports, and other necessary documentation, as appropriate, to the defined Quality Role within the applicable regulations and WuXi AppTec Policies and Standard Operating Procedures.
  • Review, approve or reject all components and batch records, where appropriate.
  • Review and approve GMP SOPs.
  • Review and approve change controls in cGMP.
  • Ensure compliance to cGMP, Quality System Regulations and ISO standards.
  • Perform in-process and final acceptance activity inspections (testing and manufacturing) and appropriately documents the results.
  • Conduct internal and external audits.
  • Perform QC review activities, where applicable.
  • Ensure, if errors occur, appropriate identification and oversight of QA CAPA activities (nonconformities, lab investigations, OOS, complaints, etc.).
  • Assist QA leadership in the development and implementation of updates to the company GMP program for adherence to applicable regulations and standards.
  • Perform Management metrics and assist with QA Management Review.
  • Perform risk assessment of the Quality system.
  • Develop and provide cGMP training for QA and technical laboratory personnel.
  • Work with colleagues throughout the company to encourage cooperation, train and implement Quality Systems and disseminate regulatory knowledge.
  • Maintain GMP documentations.
  • Ability to work in a team environment and independently.
  • May be required to work weekends.
  • Contributes to the overall operations and to the achievement of departmental goals.
  • May be required to work Overtime.
  • Other duties as assigned.
 

Qualifications

Experience / Education:
  • Thorough understanding of Good Manufacturing Practices, Quality System Regulations and ISO standards.
  • Minimum 7 years of GMP and QA experience.
  • Audit experience is a plus.
  • Bachelor’s Degree or higher in a scientific discipline.
Knowledge / Skills / Abilities:
  • Thorough knowledge of commonly used technical concepts, practices, and procedures within the analytical and QA fields.
  • Proficient Oral & Written communication skills.
  • Detailed oriented and highly organized.
  • Need to be able to read, write and understand English.
  • Proficient in Microsoft (Excel, Word, Outlook).
  • Ability to multitask and work under pressure of multiple projects and tight timelines.
  • Able to record and keep essential records for a regulated environment.

WuXi AppTec

Posted on: June 24, 2020

Closing: July 24, 2020

Salary($): 70,000 – 99,999

Position Type: Full Time

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Career Focus: Chemistry, Quality,

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