+32 494 04 21 32
The QA Officer provides substantial support to the Head of QA in all matters related to GMP/GDP processes and product quality for all affiliates. QA Officer gives general administrative support to the Head of QA.
- Preparing EU batch release by collecting all necessary information from suppliers as well as preparing bulk batch release and perform the first screening of the documents. Updating batch and electronic register. Interacting with external warehouse contractor to perform necessary activities.
- Order QC analysis with registered analytical labs and follow-up. Initiating investigation and preparing, if required, deviation reports and CAPA’s linked to batch release. Organizing the collection of samples.
- Prepare administrative release, initiate investigations & CAPA’s, prepare deviations linked to administrative release
- Provide support linked to the distribution of medical samples.
- Assist in maintaining the manufacturing license in accordance with legislations, guidelines and requirements. Assist in verifying compliance and audit compliance status of all contractors. Assist in the implementation of self-inspections and follow up of corrective actions.
- Preparing draft SOPs which are part of the QMS. Follow-up and maintain QMS in line with GxP, legislation, guidelines and global policies.
- Updating register for psychotropics and narcotics. Requesting import and export licenses. Monthly reporting to FAGG / AFMPS.
- Ordering sequential barcodes on request of manufacturing sites for reimbursed products. Trimonthly reporting to RIZIV / INAMI.
- First contact in case of complaints, registration & follow-up on complaints. Archive the related documentation.
- Coordinate change control activities, complaints and deviation process. Update technical files after approval change control.
- Review of returned goods, ensure traceability of the batches, provide support for recalls.
- In line with Global policies: prepare PQR’s (Product Quality Review), provide support for set-up and maintenance of ongoing stability studies.
- Assist in organizing trainings. Follow-up on the overall training compliance status of all staff members. Update and archive training records.
- Responsible for the transmission of quality complaints and adverse events to the responsible person and local representative for Pharmacovigilance within 24 hours via e-mail or telephone.
- Scientific background (Pharmacist, Biomedicus, Pharmaceutical Laboratory Assistant …)
- 2 to 5 years of experience in a similar job or working environment
- Experience in working with SAP is an advantage
- Fluent in English with a good working knowledge of Dutch or French.
- Excellent interpersonal skills to assist in liaison with other departments within/outside the group in order to support quality requirements
- Problem solving
- Good written and oral communication
- Hands-on mentality
- Strong sense of responsibility
- Capable to adapt in a fast-moving environment and able to deal with tight deadlines
- Excellent organization and project management skills
- Be able to work autonomously.