Description
One of our clients, a multinational company in the pharmaceutical industry currently requires a QA Validation Compliance Support to provide QA support to method validation and review for the QC department
Start: 2/9
Length: 24 months
Location: South of Brussels
Function description:
- Provide QA support to method validation and review for MPU QC,
- Maintain the compliance level of method validation with regulatory standards.
Key Responsibilites:
- Ensure QA compliance in all method validation activities (validation, transfer, periodic assessment)
- Representation in meetings: semestrial meetings - QA QC departmentteam
- Escalate L1 deviation
- Review and challenge the validation deviations (except productimpact) and CAPA of the QC department
- Ensure the implementation of capa
- Approve validation deviation (L3) (and L2 by delegation of itsmanager) and related CAPA in accordance with procedures and timelines.
- Ensure the implementation of capa
- Review at least on monthly basis the quality system status of its QC department (D0, CP, RPC/R2 )
- Review and challenge the QC change controls (R1 - R2) in accordance with procedures (Matrix) and timelines.
- Approve QC minor changes (R2) (and R1 by delegation of its manager)in accordance with procedures and timelines.
- Approve QC SOP related to its QC department in accordance with procedures and timelines.
- Perform L2 and L1 audits.
- Perform QA on the floor program in QC.
- Report any major event to its QA management.
- Ensure implementation of cGMP training program and qualification ofits QC department.
- Approve the validation documentation regarding the GMP requirements and the clients procedures:
method validation protocols and reports, method transferprotocols and reports (R&D to QC, intra QC), method periodicassessment (~RVA)
- Provide a compliance expertise during use and development of validation standards and/or validation characteristics.
- Follow and Ensure the implementation of pharmacopoeia updates
Prerequisites:
Education
* University Scientific Degree (Master) in a general Science or LifeScience Degree (Pharmacy, Chemistry, Bio Engineer, Biology, Biomedical Sciences).
Knowledge:
- Good knowledge of current good manufacturing practices inbiopharmaceuticals and validation processes
- GMP and GLP knowledge (method validation included)
- Good knowledge of English (written and spoken)
Experience:
- First experience during 2, 3 years in QC, Validation or QA in a biopharmaceutical industry
Tags: Pharmaceutical, Pharmaceutique, GMP, GLP, Validation, QC, QualityControl, Contrôle qualité, QA, Assurance qualité, Quality Assurance