Description
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