Our client is a global leader having recently completed a major
restructuring of its Quality organisation, resulting in a number of
new opportunities to impact the function at global level.
The Quality Compliance Lead will be the person responsible for all
activities related to regulatory authority inspection as well as
associated inspection readiness activities.
This role spans the biologics portfolio, with internal and external
manufacturing partners.
JOB DELIVERABLES :
* Ensure inspection readiness activities are carried out at internal
and external supply sites including reporting, identification and
mitigation of inspection risks, development of risk and mitigation
action plans
* Host external Biologics inspections both locally and at external
supply locations (or ensure appropriate co-hosts are identified &
trained)
* Ensure inspection responses are appropriately managed including
responses, CAPA planning etc
* Maintain Site Master Files as well as site licenses, renewals and
inspection documentation
* Manager the Quality Counsel for external supply
PERSON SPECIFICATION :
* Broadly experienced quality professional, conversant in DP, DS,
fill & package for biologics or aseptic processing.
* Strong knowledge of cGMP/GLP regulations, ICH, FDA CMC Guidance
Documents and other Regulations.
* Strong technical, interpersonal, communication and leadership
skills.
* Strong organizational and thinking skills.
* Degree in a scientific/technical discipline - additional
function-specific qualifications advantageous
Our client is a global leader having recently completed a major
restructuring of its Quality organisation, resulting in a number of
new opportunities to impact the function at global level.
The Quality Compliance Lead will be the person responsible for all
activities related to regulatory authority inspection as well as
associated inspection readiness activities.
This role spans the biologics portfolio, with internal and external
manufacturing partners.
JOB DELIVERABLES :
* Ensure inspection readiness activities are carried out at internal
and external supply sites including reporting, identification and
mitigation of inspection risks, development of risk and mitigation
action plans
* Host external Biologics inspections both locally and at external
supply locations (or ensure appropriate co-hosts are identified &
trained)
* Ensure inspection responses are appropriately managed including
responses, CAPA planning etc
* Maintain Site Master Files as well as site licenses, renewals and
inspection documentation
* Manager the Quality Counsel for external supply
PERSON SPECIFICATION :
* Broadly experienced quality professional, conversant in DP, DS,
fill & package for biologics or aseptic processing.
* Strong knowledge of cGMP/GLP regulations, ICH, FDA CMC Guidance
Documents and other Regulations.
* Strong technical, interpersonal, communication and leadership
skills.
* Strong organizational and thinking skills.
* Degree in a scientific/technical discipline - additional
function-specific qualifications advantageous
We need : English (Good)
Type: Permanent
Payment:
Category: Others
