Abbott Hiring MANAGER PRODUCTION B.Pharm / M.Pharm Apply Now
JOB
RESPONSIBILITIES :
Ensure
that current Good Manufacturing Practices and Good Documentation practices
shall comply at Granulation & Compression.
Responsible
for investigation of exception / non-compliance in the production area,
preparation and review of investigation report.
Implementation
of Quality Management System as per cGMP and international requirement at
Granulation & Compression.
To
perform root cause analysis for the exception / non-compliance.
Person
shall be responsible for product line clearance, Machine operation &
cleaning, batch reconciliation.
Perform
the GEMBA with cross functional team including Quality Assurance, Engineering,
Warehouse and Quality Control etc. to investigate the exception /
non-compliance.
Preparation
and review of CAPA report (Corrective action and Preventive Action) and follow
up for implementation.
Provide
support and guidance to improve the right first time of the production batch /
batch documents.
Handling
of change control and preparation of required documents for change control.
Impart
training to workman on shop floor for GxP activities.
SOP
preparation, review and gap identification as per guideline and Abbott Quality
system requirements.
Preparation,
review of protocol and report (Technical / Study / Non-routine / Reprocessing /
Repacking) on need basis.
Audit
preparation and compliance for the audit observation.
Prepare
short term plan for to ensure achievement of budgeted volumes and timely
deliverance of product with quality.
To
Prepare plan for man and equipment management.
People
management (responsibility for leading, motivating, training and developing the
subordinates).
Ensure
that initial and continuing training of department personnel is carried out and
adapted according to need.
Ensure
that the appropriate qualification and validations (Equipment, Process and
Utilities ) are carried out in the Granulation and Compression area.
Co-ordination
with other support function for effective implementation of action item
identified.
Identify
the training needs of the team and ensure the fulfillment.
Ensure
compliance of all procedures, practices and system to cGMP with respect to
Schedule M, WHO guidelines, Abbott Quality guidelines, other applicable
regulatory guidelines and Standard
Operating procedures at site.
Ensure
that Good Documentation practices shall be comply during production process.
Internal
and External co-ordination such as Production, Planning and Control, QA,
TechOps, Engineering, HR Department, I&D etc.
Decision
making. Operational - Tracking, monitoring and closure of action plan and CAPA.
Mitigation
plan if required during operation.
Any
other activities/support as instructed by the superiors as and when required.
In
absence of the position holder, the subordinate Executive / Manager working in
the section or authorized designee (as applicable) shall be responsible for day
to day working.
EXPERIENCE
REQUIRED :
B.Pharm
/ M.Pharm with 10 – 15 years of experience
Incumbent
having experience in core manufacturing / at the shop floor operations of
pharmaceutical company
Should
have expertise in Granulation & Compression Department
Well
versed with CAPA, GMP Documentation, QMS
Should
have exposure to regulatory audits such as MHRA, USFDA etc.
TO APPLY CLICK HERE
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