Lonza

ComplianceCoordinator,QualityControl

Gelezen FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Mid+ candidates.

The Brief

“Compliance Coordinator, Quality Control at Lonza. Skills: Quality Control, Compliance, Documentation. Ensure Quality Control readiness for GMP and pre-approval inspections. Define appropriate quality events and coordinate their completion”

What You'll Achieve.

reduce the number of events; contribute directly to the quality and safety of life-changing therapies

Industry & Context.

Problems you'll solve

Problem solving and analytical mindset; troubleshoot testing in area of expertise

What They're Looking For.

Must Have

experience working within the laboratory, Problem solving and analytical mindset, Confident to communicate with stakeholders and conduct investigations, ability to interpret data and troubleshoot testing in area of expertise, Displays a calm and controlled demeanor in all situations

What You'll Do.

Ensure Quality Control readiness for GMP and pre-approval inspections

Define appropriate quality events and coordinate their completion

Support process improvement initiatives for quality issues

Act as point of contact on accountabilities

Report and review SOPs and WIs

Maintain compliance as per Lonza documentation and GMP regulations

Support consistent adherence to compliance through participation in audits

review and define quality events

Coordinate implementation and closure of quality events

review and revise SOPs

Contribute to batch disposition in coordination of quality events

Suggest and implement continuous improvement in Quality control process

Support site wide quality improvements and process improvement

Take initiative in quality issues

How You'll Work.

Team & Collaboration

coordinate their completion through the Quality control team; communicate with stakeholders; in conjunction with the wider organization

Communication Scope

Confident to communicate with stakeholders

Full Job Description

**Compliance Coordinator, Quality Control Location: Geleen Full Time, On Site.** We are looking for a **_Compliance Co-ordinator within Quality Control_** to join our company, ensuring Quality Control readiness for GMP and pre-approval inspections. Defines appropriate quality events and coordinates their completion through the Quality control team to reduce the number of events. Supports process improvement initiatives for quality issues. Is point of contact on accountabilities outlined below. Reports and reviews SOPs and WIs. Maintains compliance as per Lonza documentation and GMP regulations. **What you will get:** * A varied laboratory role with the opportunity to grow skills across several QC disciplines. * Hands-on experience with a wide range of assays, techniques and GMP processes. * A supportive team environment with training, coaching and clear development pathways. * The chance to contribute directly to the quality and safety of life-changing therapies. **What you will do:** * Supports consistent adherence to compliance through participation in internal and external audits. * Initiation, writing, review and defining of appropriate quality events (deviations, SAIs, change controls, CAPAs, effectiveness checks and child records) and coordinates implementation and closure within agreed timelines. * Initiation, review and revision of SOPs, protocols, reports, WIs and other relevant GMP related documentation within agreed timelines. * In coordination of quality events, contributes to batch disposition. * Suggests and implements continuous improvement in regards to Quality control process, planning and training. * Supports site wide quality improvements, process improvement and takes initiative in quality issues in conjunction with the wider organization. **What we are looking for** * Ideally someone who has experience working within the laboratory * Problem solving and analytical mindset * Confident to communicate with stakeholders and conduct investigations *

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