QA Operations Specialist
Permanent / CDI
We are working with a global Pharmaceutical client with sites throughout Europe and the wider world. They are seeking a Quality Assurance Operations Specialist in Brussels.
The QA Operation Specialist will be working as part of our Pharmaceutical clients Quality Assurance Department and ensure that the products are manufactured, stored, packaged and shipped in accordance with cGMP rules.
They will support the development of GMP training packages and, if necessary, delivery of training. Under the direction of the reporting Manager, he / she will continuously improve the Quality Management System (QMS), strengthen quality awareness and investigate quality issues using applicable process improvement and problem solving techniques to maintain the required compliance level and assure successful outcomes of Customer audits and Health Authority inspections.
What You’ll Do:
Provide QA Support For:
- Initiation, recording, investigation and closure of Deviations and Out Of Specifications (OOS).
- Change Controls initiation, recording, implementation and closure.
- CAPA plans initiation, recording, implementation and closure.
Documents And Records Review:
- Procedures, Master Batch Records, Specifications…
- Batch Records (Production and QC) and associated documents (Records, Deviations, Changes and CAPAs)
- Control files and release of production installations.
- Follow up of the calibration program and the monitoring for the facilities, review and archiving of related records.
- PQR (Product Quality Review) / Compiling, reviewing and processing of batch data and writing of PQR.
Documentation System Management:
- Traceability (controlled copies, document approvals follow-up…).
- Distribution of effective QMS documents.
- Maintain the training files and the archives area up to date.
- Work with relevant departments to ensure timely closure of Quality actions
- Actively contribute to continuous improvement initiatives (new business processes or reorganized activities, new Computerized Systems…)
- Perform self-inspection activities (routine inspection of the facilities, internal audits…)
- Collaborate with the different departments to resolve compliance matters
- Actively contribute to prepare, conduct and success of customer audits and regulatory inspections.
Masters degree plus several years of experience in Pharmaceutical QA.
- Good knowledge of cGMP in a regulated environment (ICH Guidelines)
- Excellent precision, rigor and ethics in work and attention to details.
- Excellent interpersonal skills.
- Working knowledge of MS office packages (Word, Excel, Power Point) and TrackWise® System or similar systems is in asset.
- Strong problem solving skills, issue resolution and root cause analysis.
- Highly Flexible with high adaptability. Able to work independently in a multitasking environment.
- Good ability to write comprehensive, complete and concise reports.
- Language: French, English with a minimum understanding and writing level required.
On this occasion, LiCa Scientific is acting as an employment agency.