Analytical Lifecycle Qc Manager

il y a 1 semaine


Lessines, Wallonie, Belgique Takeda Pharmaceutical Temps plein

About the role:

Objectives/Purpose:

  • Support all analytical method troubleshooting at the quality control
  • Develop new state of the art method to increase efficiency and reduce lead time and workload. Support the Process Analytical Technology (PAT) Initiatives
  • Maintain and improve all analytical method and associated critical reagents

How you will contribute:

Accountabilities:

  • Assure GMP compliant and methods implementation/maintenance
  • Plan method development, validation or improvement activities and make sure they are completed on time, review and approve related documents
  • Manage activities to support QC key projects (e.g. assay transfers), review and approve related documents
  • Maintain critical reagents and standards
  • Identify, lead and drive improvements, remediation or troubleshooting for analytical essays
  • Lead analytical assay investigations or problems solving (OOS, CAPA, invalids, etc.)
  • Drive assays improvement
  • Identify breakthrough Analytical method which will increase efficiency, reduce workload and reduce lead time
  • Support to any PAT initiatives
  • Identify external interactions (e.g. Contract Laboratories and Vendors)

Support MoH audits :
assure inspection readiness, act as SME if required

Change Control management:

  • Plan change requests related to QC analytical methods
  • Assure implementation of change requests in a timely manner
  • Work with RA and CMC leads for submissions
  • Local relay for QC related divisional procedures : support Global initiatives to assure local implementation (e.g. quarterly review of invalids results, assessment of Pharmacopoeial updates follow by implementation if requested)
  • Manage the Analytical Lifecycle team

Core elements related to this role:

  • Maintain and improve analytical method and critical reagents associated is a mandatory position to continuous supply the patient worldwide.
  • Transforming the analytical method in state of the art method oriented in the future is a must to transform the lab to meet future expectations of patient (reduce cost, lead time)

Dimensions and aspects:

Technical/Functional (Line) Expertise- Good laboratory technical background and knowledge of main analytical tools

More specifically:

  • Knowledge in analytical methods
  • Knowledge in analytical method validation and critical reagent qualification
  • Knowledge in statistical and experience with data analysis
  • Knowledge about regulatory requirements concerning analytical methods
  • Strong knowledge of requirements related to quality control (local and global SOPs, cGMP, CFR, Pharmacopeia (EU/US/JP/China)
  • Good English knowledge (proficiency level) and communication skills (verbal and written, including technical writing)
  • Technical writing skills
  • Fluent in French and English
Leadership

  • Targetoriented
  • Critical thinking
  • Staffing, organization and development of Quality Control Subject Matter experts
  • Strong communication and organizational skills
  • Setup goals and projects for team members to achieve daily operations goals as well as strategic quality goals
  • Represent plant in global projects, communities and initiatives
Decision-making and Autonomy

  • Analytical thinking
  • Problem solving skills
  • Decide on new analytical techniques and orientation
Interaction

  • Report to the Head of Quality Control & Microbiology
  • Benchmarking inside and outside Takeda
  • Interacts with site quality functions and other departments (EHS, HR, Finance, IT, Manufacturing, Engineering, Supply Chain, Procurement)
  • Cooperation with other Takeda facilities, QC labs and process related facilities and functions (global QC, PDTS and external partner)
  • Has external interactions with Contract Laboratories and Vendors
Innovation

  • Open to new analytical technology including PAT
  • Identify digitalization and robotics option
  • Be informed about technical innovation and available upgrades potentially applicable to QC Analytical method or instruments
  • Active participation to Global councils and forums in order to be informed about best practices across the QC Network and to receive updates from other sites and Global QC functions
  • Drive and manage a culture of continuous improvement within the area of responsibility (5S, Tier structure, 6 sigma, Labex) and leading problem solving activities (using 6 sigma tools)
Complexity

  • Must be able to work in controlled GMP area and be aware of requirements and risks associated with laboratory environment
  • Handling of hazardous and biologic materials
  • Achievement of defined goals and targets in order to drive the QC to reach operational and compliance excellence
  • Manage CAPEX budget within area of responsibility

What you bring to Takeda:

  • Master, Engineer or PhD from technical, pharmaceutical, chemical or biological college or university with practical experience of a quality control function or related area preferably in pharmaceutical industry
  • At least 5 years of management experie

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