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Engineering QMS
1 week ago
Biocon Biologics represent the cutting-edge of biomedical research, and biosimilars present an enormous opportunity to provide affordable access to these advanced therapies.
Biosimilars are intended to increase patients' access to biologics as they are priced lower than branded, novel biologics and may further lead to the competitive pricing of the original biologic.
Biosimilars can ensure a greater and more equitable access to biologic therapies and to healthcare generally.Biosimilars are projected to generate US$290 billion in savings around the world through 2027, according to IQVIA's Global Use of Medicines Report for 2023.
Biocon Biologics is today one of the frontrunners in the global biosimilars industry, working to provide patients access to affordable biologics and enable health equity worldwideJob Responsibilities:
Change controls, CAPA, Deviations, Training records And SOPs preparations till effectiveness etc.
of all QMS in track wise
of routine RQ & Validation of HVAC systems, compressed gases and equipment's.
review and updating of Fill Finish layouts.
in VMP & SMP
of equipment qualification documents.
and execution of preventive maintenance planner for the equipment.
of audit responses,
the cGMP, GDP and safety while carrying out all activities
and supporting for online completion of change controls, deviations, CAPA for the entire facility for fill finish area.
of monthly reports and utility consumption reports and analysis.
to department Personnel.
good co-ordination with Cross Functional team to sort out QMS issues.
all Equipment related manuals and records.
in coordination with Maintenance team and reporting them if any deviation observed.
of Preventive maintenance checklists, log books, history cards, test reports etc.
for all documents handling during the Audits from the engineering and maintenance archival.
with external vendors for documents requirements.
for all layouts displayed in area & routine layout revisions.
for handling of Risk assessments (Failure Mode, Effects and Criticality Analysis).
onsite team to perform risk management activity, identify Gaps and remediate accordingly.
for ensuring the compliance of cGMP non- conformance within stipulated timelines through the proactive participation in investigations and Root cause analysis/CAPA activities, compilation of investigation reports, coordinating corrective and preventive action execution and performing CAPA effectiveness checks in Track Wise system.
for staff training and developments.for ensuring the maintenance of good quality standards and maintaining of record SOP reviewing and preparation of modified/new SOP.
for reviewing the documents to meet GMP compliance.
for preparation of QMS monthly report & daily reports for tracking.
Revising, IQ, OQ, PQ, RTM for CQV and follow up for completion as per the CQV schedule and tracker. Conducting internal/external audits.
Educational Qualification :
B. Tech Mechanical/ Electrical/ Electronics/ Instrumentation
Experience: 12 to 15 years
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