* Experience of leading C &Q process equipment teams to completion of
IOQs protocols ( **Apply on the website** people of various skill
levels in each team)
* Strong understanding of C &Q leveraging approach
* years track record of Process equipment C &Q execution, ideally
involving sterile fill finish equipment
* Experience managing issues with Quality team
* Experience of some of the following equipment
* Lab autoclave, washer and purified water systems
* Semi automation and manual inspection equipment
* Fridges, freezers and colds rooms
* Down flow booths for sampling and preparation of batch excipients
Job responsibility
* Review FAT/SAT executed protocols for leveraging and adjust IOQ
protocols to support leveraging
* Generation pf protocols to meet Abbvie corporate requirements
* Manage change controls and updates to PURS, SLIA FMEA, CE and DQRTMS
as required
* Review final contractor and vendor documentation and manage any gaps
in documentation
* Issue weeks and month progress updates to senior management Experience
* Experience of leading C &Q process equipment teams to completion of
IOQs protocols ( **Apply on the website** people of various skill
levels in each team)
* Strong understanding of C &Q leveraging approach
* years track record of Process equipment C &Q execution, ideally
involving sterile fill finish equipment
* Experience managing issues with Quality team
* Experience of some of the following equipment
* Lab autoclave, washer and purified water systems
* Semi automation and manual inspection equipment
* Fridges, freezers and colds rooms
* Down flow booths for sampling and preparation of batch excipients
Job responsibility
* Review FAT/SAT executed protocols for leveraging and adjust IOQ
protocols to support leveraging
* Generation pf protocols to meet Abbvie corporate requirements
* Manage change controls and updates to PURS, SLIA FMEA, CE and DQRTMS
as required
* Review final contractor and vendor documentation and manage any gaps
in documentation
* Issue weeks and month progress updates to senior management
We need : English (Good)
Type: Permanent
Payment:
Category: Others
