Job Vacancy for Experienced
in Production / Micro -Parenterals @Narasaraopet, Guntur Dist.
Greetings of the Safe Parenterals
Pvt. Ltd., (A Pranaya Group) Jobs...!!!
We have an Urgent requirement for the
following departments
Department: Microbiology
(Injectable Experience)
Position:
Incharge
Experience -5-7 years
Openings: 01
Location: Safe Parental, Narasaraopet, Guntur Dist.
Qualification: B.Pharm
and M.Pharm-Pharmacy
Job Description: NOTE:
Please Mention in Subject as "Microbiology Incharge"
· Microbial
Analysis of Water and Finish Product and Raw Material.
· Sterility
Testing For Finish Product and Raw Material
· Swab
and Bioburden test.
· Staining
Method.
· Culture
Maintain and Culture Preservation.
· Growth
Promoting Test.
· Autoclave
Operation
· Daily
Temperature Monitoring of Incubator.
· Participate
in Media fill Validation Process.
· Environmental
Monitoring, and Water Sampling
· Media
Preparation.
· Media
fill
· BET
of Water and Finish Product of Sample.
· Trend
Analysis of PW and WFI and EM
· Regulatory
knowledge & guidelines – GLP, Schedule M, ICH, WHO TRS etc
Please
share interested profiles to hr.corporate@pranayagroup.
Department: Production (Injectable
Experience)
Position:
Incharge
Experience -12-15 years
Openings: 01
Location: Safe Parental, Narasaraopet, Guntur Dist.
Qualification: B.Pharm
and M.Pharm-Pharmacy
Job Description: NOTE:
Please Mention in Subject as "Production Incharge”
Job Description:
· Ensuring
the execution of validation activity of Formulation, Filling & Material
Preparation Area/equipment’s dedicated with co-ordination with QA or internal
and external agencies as per validation schedule.
· Responsible
for review of SOP’s, validation protocols, extended documents/reports
preventive maintenance schedule, log books, calibration schedules and
regulatory guidelines.
· To
ensure the cleaning, operation, documentation & maintenance of all dispensing,
formulation, filling, solution & material preparation area as per
production planning.
· To
evaluate and monitor the training need of the immediate subordinates and
arrange for the on job training for the staff.
· To
ensure GMP compliance as per the applicable National and International rules
and guidelines such as Schedule M and WHO.
· Coordination
with other departments, R & D and other manufacturing sites for technology
transfer of production process.
· Coordination
with Warehouse/QA/QC/RA/HR/
· Planning
& Execution of medial fill activity as per schedule.
· To
manage & coordinate the supply chain of products being manufactured at
site.
· To
create an organization culture where people believe in building process
capability by building functional capability (Functional capability to serve
process objective).
· Responsible
for handling incident & deviation, their root cause evaluation &
effective CAPA compliance w.r.t. minimize the re-occurrence of same type of
incident.
· Responsible
to ensure the online documentation as cGMP along with routine log book
management of production activity & equipment.
· Development
of Subject Matter Expert (SME) for better production activity.
· To
prepare and or review the assessments associated to the software or GXP
equipment’s.
· To
prepare and or review the DIM associated to the Software or GXP equipment’s.
Competencies
· Must
understand Aseptic Behavior – (aseptic handling, aseptic working & aseptic
cleaning).
· Must
understand Sterile Operations, Scientific practices & process criticalities
of Injectable manufacturing.
· Analytical
approach – Good in trend analysis, data evaluation & process calculations.
· Adequate,
Timely & Quality deliverance/ Output within stipulated timeframe.
· Regulatory
knowledge & guidelines – Schedule M, ICH, WHO TRS, ISO.
· Thorough
understanding of PQS & its compliances with risk based approach and patient
safety.
Please share interested profiles to hr.corporate@pranayagroup.com and samhitha.hr@pranayagroup.com
Regards,
Samhitha K
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