SYNGENE
Career Opportunities: Formulation Packaging and Operations M. Pharm or B.Pharm
Job
Title
Packing
Development and Operations
Position
Associate
Manager
Required
Educational Qualification
M.
Pharm or B.Pharm having 9-12 years of experience in pharmaceutical packing
development and packing operations is required. Diploma in packaging operation
from reputed packaging institutes will be an added advantage.
Required
work experience 9-12
years
Job
Location Bangalore
Required
Skill sets
Experience
in Pharmaceutical Packaging and Operations & Manufacturing, Serialization
Track & Trace.
Knowledge
of Packaging development, packing process validation, finalization of packaging
change parts, evaluation of Packaging materials, and machines
Job
Purpose
Responsible
for Supervision, documentation, upkeep, facility maintenance, cGM compliance
for packaging development and packaging operations at formulation manufacturing
facility for human and animal health for oral solids, injectable and semisolids
dosage forms.
Primary
Job Responsibilities
Experience
in Pharmaceutical Packaging and Operations & Manufacturing, Serialization
Track & Trace,
Knowledge
of Packaging development, packing process validation, finalization of packaging
change parts, evaluation of Packaging materials, and machines.
Change
parts qualification, new packing equipment qualification.
Technical
knowledge and hands on experience of operating of Blister packing machines like
BQS, IMA PG, CAM NMX etc.
Technical
knowledge and hands on experience of operating Bottle pack machines.
Technical
knowledge and hands on experience of operating Cartonator - IC 150(IMA PG),
CP150.
Technical
knowledge and hands on experience of operating Printers such as Image,
Videojet, Wolke printers.
Technical
knowledge and hands on experience of operating Sachet/pouch packing.
To
ensure Quality and compliance and facility readiness for client visit/ audits.
To
ensure logbooks update, log sheets tracking and review of facility documents.
Experienced
in regulatory compliance requirements (e.g. USFDA, MHRA, WHO, TGA).
Initiation
of Change control for procedural revisions, changes in facility.
Procurement
activity for consumables, instrument & equipment qualification.
Preparation
of URS, review of DQ, IQ, OQ. Preparation & execution of PQ.
To
ensure preparation & revision of SOP/IOP/EOP/ECC
Supervision,
execution, planning & execution of clinical batches & registration
batches manufacturing and packing activities.
To
ensure cGMP training on a scheduled manner to all concerned personnel.
To
ensure compliance to quality system procedures & documentation as per
organizations requirements.
Hands
on experience knowledge of Track-wise, SAP and Documents management system.
People
management, Learning & training:
To
review contract people daily work.
To
ensure training to all on procedures.
Secondary
Job Responsibilities
To
ensure and implement procedures to target Zero Incidents.
To
ensure preparation of Risk Assessment
To
ensure proper Housekeeping and to circumvent EHSS Violations.
PPE
compliance.
To
support Project Execution.
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