Quality Assurance Specialist
€3500 to €4000 *14.42
Permanent / CDI role
We are working with a multinational pharmaceutical company in Brussels, Belgium who are seeking a Quality Specialist. Our clients expertise is in supplying pharmaceutical and biotechnology companies with small to commercial stage cGMP peptide API manufacturing, using world-class cost effective production processes. They have developed a portfolio of innovative technologies with the objective to shorten synthetic processes and reduce the number of steps , control quality and simplify HPLC purifications.
What you’ll do:
Reporting to the Head of Quality, the Quality Assurance Specialist will be working as part of our clients Quality Assurance Department and ensure that the products are manufactured, stored and packaged in accordance with cGMP.
He / she will also 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 QA and Compliance systems, strengthen quality awareness and investigate quality issues using applicable process improvement and problem solving techniques to assure successful outcomes of Company and external Health Authority inspections.
You will provide QA support for :
- Investigation and closure for the Deviation and the Out Of Specifications
- Change Control initiation and implementation
- CAPA initiation and implementation
- Documentation and records review :
- Procedure, Master Batch Record, Specifications…
- Batch records and associated documents after production
- Control Cleaning Records
- Maintain the calibration program and the monitoring for the facilities up to date
- Documentation System Management:
- Traceability (controlled copy, follow-up approvals,…)
- Official documents distribution
- Maintain the training files and the archives area up to date
- Other activities:
- Work with relevant departments to ensure timely closure of quality actions
- Actively contribute to continuous improvement initiatives
- Perform inspections/internal audits
- Collaborate with the different departments to resolve compliance matters
We are seeking a candidate with several years in a QA position in a GMP environment, degree level science, the language requirements are English and French.
You will also have some or all of the following skills and experience:
- Good knowledge of cGMP in a regulated environment (ICH Guidelines)
- Excellent accuracy and attention to detail
- Excellent interpersonal skills
- Working knowledge of MS office packages (Word, Excel, Power Point) and TrackWise® System is in asset
- Strong problems solving skills, issue resolution and root cause analysis
- Highly Flexible and Adaptable. Able to work independently in a fast paced multitasking environment
On this occasion, LiCa Scientific is acting as an employment agency.