Quality Associate I/ii - London, United Kingdom - Marken

Marken
Marken
Verified Company
London, United Kingdom

3 days ago

Tom O´Connor

Posted by:

Tom O´Connor

beBee Recruiter
Description

Title:

Quality Associate I/II- Cell and Gene Therapy

Location:
We are open for this position to be located in: Dublin, Frankfurt, Paris, Brussels, Amsterdam, London, Milan, Stockholm, Vienna, Edinburgh


Main Purpose:


The CGT Quality Assurance Associate (CGT QAA) is responsible for the oversight and implementation of the Marken Quality Management System (QMS), Marken Standard Operating Procedures (SOPs), processes and policies required to manage and control Marken's Cell & Gene Therapy Network.


The CGT QAA also needs to ensure compliance with applicable regional and local regulations and requirements, and client requirements as appropriate, but not limited to: current Good Manufacturing Practice (GMP), Good Distribution Practices (GDP), Good Documentation Practices (GDocP), 21 CFR Part 210 and 211.


Main Duties and Responsibilities

  • Write the quality processes and procedures associated with job role with management guidance and effective controlled document approval.
  • Implement, promote and maintain Marken's Global Quality Management System (QMS) requirements.
  • Assist in the Management of deviations, complaints, audit records, CAPA plans, change controls, collation of quality metrics and trending, and identification and implementation of quality improvement initiatives.
  • Evaluate the risk and impact of changes within scope of the CGT/QA team and advise on necessary actions, as applicable.
  • Interact with clients on Quality Assurance (QA)/ GxP related matters under management supervision.
  • Assist in internal audits including tracking of associated corrective and preventative actions (CAPA).
  • Support Client audits and Regulatory Inspections
- participate as a QA SME, prepare requested materials, review/approve Marken audit responses, follow up on CAPA identified.

  • Effectively interact with Marken operational departments and stakeholders to provide guidance and quality oversight of all CGT activities ensuring alignment to Marken's QMS.
  • Identify relevant GxP/Quality related training needs and deliver or make they are deliver where required.
  • Keep informed of regulatory changes within assigned _Country/Region_ and promptly escalate changes to management.
  • Assisting in the evaluation of Markendesignated vendors and/or outsourced activities.
  • Ensuring the accuracy and quality of records and documents.
  • Participate actively in all the internal Quality, CGT and/or other pertinent meetings.
  • Travel may be required for the performance of duties.

General

  • Fluent In English. Multilingual (desired), dependent on recruiting area.
  • Demonstrated knowledge of GxP regulations
  • Good Manufacturing Practices and/or Good Distribution Practices.
  • Organized, methodical and efficient approach to work.
  • Excellent verbal, written, and interpersonal communication skills.
  • Demonstrated ability to prioritize tasks.
  • Demonstrated ability to effectively communicate and collaborate with direct stakeholders including with customers, vendors, equipment suppliers, and operations staff.
  • Perform activities assigned by the QA Management.
  • Support QA team to ensure a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management.
  • Demonstrated commitment to integrity and transparency.

Requirements:


  • Bachelor's degree required.
  • Relevant technical experience and/or quality experience in a GxP industry or the equivalent combination of relevant education and professional experience

(Associate I:


1-2 years; Associate II: 3-5 years):

  • Navigating an electronic QMS system
  • Hands on experience with execution of quality records in a GMP regulated environment (e.g., deviation handling, change management, risk management, CAPA management, Quality Agreement execution)
  • Demonstrated knowledge of Good Manufacturing Practices, Good Distribution Practices, Good Documentation Practice guidelines.
  • Related knowledge of local regulations.
  • Detailed oriented.
  • Organized, methodical and efficient approach to work.
  • Excellent verbal, written, and interpersonal communication skills.
  • Demonstrated ability to prioritize tasks.
  • Demonstrated ability to effectively communicate and collaborate with direct stakeholders including with customers, vendors, equipment suppliers, and operations staff.
  • Proficient use of Microsoft Office

Marken is a wholly owned subsidiary of UPS and is a critical part of UPS Healthcare. Marken offers a state-of-the-art GMP-compliant depot network and logistic hubs for clinical drug product storage and distribution worldwide, and supports cell and gene therapy logistics services from clinical to commercial, while maintaining the leading position for Direct-to-Patient and Home Healthcare services, biological sample shipments and biological kit production.


Moving Our World Forward by Delivering What Matters.
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