Safe Parenterals Pvt. Ltd - Job Vacancy for Experienced in Production / Micro -Parenterals
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
FOR JOB UPDATES
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