Analytical Lifecycle Qc Manager - Lessines, België - Takeda Pharmaceutical

Takeda Pharmaceutical

Geverifieerd bedrijf

Lessines, België

1 week geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

Beschrijving

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