Dieses Jobangebot ist archiviert und steht nicht mehr zur Verfügung.
Vakante Jobangebote finden Sie unter Projekte.
Vakante Jobangebote finden Sie unter Projekte.
QA Supervisor for QC Department
Eingestellt von Harvey Nash IT Recruitment Belgium
Gesuchte Skills: Support
Projektbeschreibung
One of our clients, a multinational company in the pharmaceutical industry currently requires a QA GMP Supervisor for Biochemistry QCdepartment
FUNCTION DESCRIPTION
- QA GMP Supervisor for Biochemistry QC department
- Provide QA support to Biochemistry QC department
- Maintain the compliance level of its QC department with regulatory and GSK standards.
Act as back up of the Manager QA Operational
KEY RESPONSIBILITIES
- Ensure QA compliance in its Biochemistry QC department
- Lead the meetings: weekly deviation meeting -
- Representation in meetings: QA QC department team
- Prepare weekly deviation meetings with QA technician if relevant.
- Review and challenge the QC deviations and CAPA of its QC department
- Escalate complex deviation
- Approve QC deviation and related CAPA in accordance with procedures and timelines.
- Review at least on monthly basis the quality system status of its QC department (D0, E3, E6, CP, RPC/R2 )
- Review and challenge the QC change controls (R1 - R2) in accordance with procedures (Matrix) and timelines.
- Approve QC changes in accordance with procedures and timelines.
- Approve QC SOP related to its QC department in accordance with procedures and timelines.
- Approve life cycle validation reports and intra-site transfer reportin accordance with procedures and timelines.
- Approve Validation plan and validation summary report in accordance with procedures and timelines.
- Present topics during inspection by delegation of its manager
- Perform QA on the floor program in QC.
- Report any major event to its QA manager
TRAINING PERIOD
At the beginning of the mission.
EDUCATION/KNOWLEDGE/PREVIOUS EXPERIENCE REQUIRED
Education:
* Bioengineer/Pharmacist or equivalent
Knowledge:
* Good knowledge of current Good Manufacturing Practices
* Good manufacturing and laboratories process knowledge
* Good knowledge of English (written and spoken)
Experience/Behaviors/Skills
* 2-5 years experience in pharmaceutical environment
* Experience in FDA/EU/WHO inspection
* Good knowledge of FDA/EU/ICH/CDN/AUS guidelines
* Quality Control experience
* Experience in biologicals manufacturing/testing processes
Tags: QA, QC, Biochemistry, GMP, CAPA, Deviations, SOP, FDA
FUNCTION DESCRIPTION
- QA GMP Supervisor for Biochemistry QC department
- Provide QA support to Biochemistry QC department
- Maintain the compliance level of its QC department with regulatory and GSK standards.
Act as back up of the Manager QA Operational
KEY RESPONSIBILITIES
- Ensure QA compliance in its Biochemistry QC department
- Lead the meetings: weekly deviation meeting -
- Representation in meetings: QA QC department team
- Prepare weekly deviation meetings with QA technician if relevant.
- Review and challenge the QC deviations and CAPA of its QC department
- Escalate complex deviation
- Approve QC deviation and related CAPA in accordance with procedures and timelines.
- Review at least on monthly basis the quality system status of its QC department (D0, E3, E6, CP, RPC/R2 )
- Review and challenge the QC change controls (R1 - R2) in accordance with procedures (Matrix) and timelines.
- Approve QC changes in accordance with procedures and timelines.
- Approve QC SOP related to its QC department in accordance with procedures and timelines.
- Approve life cycle validation reports and intra-site transfer reportin accordance with procedures and timelines.
- Approve Validation plan and validation summary report in accordance with procedures and timelines.
- Present topics during inspection by delegation of its manager
- Perform QA on the floor program in QC.
- Report any major event to its QA manager
TRAINING PERIOD
At the beginning of the mission.
EDUCATION/KNOWLEDGE/PREVIOUS EXPERIENCE REQUIRED
Education:
* Bioengineer/Pharmacist or equivalent
Knowledge:
* Good knowledge of current Good Manufacturing Practices
* Good manufacturing and laboratories process knowledge
* Good knowledge of English (written and spoken)
Experience/Behaviors/Skills
* 2-5 years experience in pharmaceutical environment
* Experience in FDA/EU/WHO inspection
* Good knowledge of FDA/EU/ICH/CDN/AUS guidelines
* Quality Control experience
* Experience in biologicals manufacturing/testing processes
Tags: QA, QC, Biochemistry, GMP, CAPA, Deviations, SOP, FDA
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
Sonstiges