Dieses Jobangebot ist archiviert und steht nicht mehr zur Verfügung.
Vakante Jobangebote finden Sie unter Projekte.
Vakante Jobangebote finden Sie unter Projekte.
QA Validation Compliance Support
Eingestellt von Harvey Nash IT Recruitment Belgium
Gesuchte Skills: Support, Engineer
Projektbeschreibung
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
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
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
Ingenieurwesen/Technik, Sonstiges