Activity

Handle FDA inspection and explain quality system along with

all quality related documents directly
Handle review of Batch manufacturing record, qualification
and validation documents
Implement all SOPs and if any deviation, is reported, to be
investigated adequately in timely manner
Adequate closure of all QMS within timeline

Market complaint to close adequately in timely manner

Any time readiness of manufacturing site

Handle FDA inspection and explain quality system along with
all quality related documents directly
Handle review of Batch manufacturing record, qualification
and validation documents
Implement all SOPs and if any deviation, is reported, to be
investigated adequately in timely manner
Adequate closure of all QMS within timeline
Investigations are to be adequate wrt root cause, CAPA and
impact assessment
Batch releases in time and without any discrepancies and
without any complaints from customers

Manufacturing is carried out as per GMP requirements,

discrepancies are reported, closed in timely manner without
impacting quality of batch, no audit observation

Provide training to IPQA team on GEMBA walk to identify

observations wrt GMP, P vs P ensuring any time audit
readiness.

Planning internal / external audit, hosting of audit to ensure

no Major or critical observations, no repate observations in
the internal audit.
Process and cleaning validations are to be carried out as per
the protocol.
Involve in all major investigations and ensure adequate
investigations are carried out

Track MOM of QGF, BU meeting and present in next meeting

Training to all QA person, to be done on timely manner and

100% compliance.
Identify NVAs / duplicate works for effective usage of work
force.
Quality Score card and KPI are tracked and met
Correct and adequate data are provided to quality head in
timely manner for senior management for quality reviews

Shift management in line with manufacturing requirements

Gaps in quality systems, practices and facility are identified

and system put in place.
Knowledge and exposure to SHE practices, comply
requirements on timely along with training to the team on
those aspects
Plan