Coral Drugs Hiring Executive/Officer – Quality Assurance / Quality Control/HPLC / Officer – Quality Control –GC / Production / Regulatory Affairs B. Pharma/M. Pharma / B.Sc./M.Sc / Apply Now
Executive/Officer – Quality
Assurance
• Compilation of Supporting
documents for Change Control/Deviation/CAPA/OOS.
• Responsible for Document Archival
& up keeping.
• Preparation of Certificate of
Analysis for Dispatch as per Sale order.
• To work & implement the
cGMP practices in to all departments as per SOPs.
• Preparation of SOPs &
relative documents.
Desirable: Minimum 03 to 08
years working experience in API post B.Sc./M.Sc./B.Pharma
Location: Murthal, Sonipat.
Executive - Quality
Control/HPLC
• Analysis of samples by
chemical method and online reporting of in process and intermediate samples and
analysis of in process validation samples.
• Analysis of samples by
methods using HPLC,.
• Thorough knowledge on
handling Validation & calibration of HPLC.
• Knowledge on handling of OOS,
Deviations, Incidents. Should have Knowledge on Wet chemistry.
• Exposure to regulatory
audits. Should have the knowledge of cGMP and Good documentation practices.
Desirable: 4 to 10 year working
experience API, post B.Sc./M.Sc. in Chemistry.
Location: Murthal, Sonipat.
Officer – Quality Control -GC
• Analysis of samples by
methods using GC
• Thorough knowledge on
handling GC.
• Knowledge on handling of OOS,
Deviations, Incidents. Should have Knowledge on Wet chemistry.
• Exposure to regulatory
audits. Should have the knowledge of cGMP and Good documentation practices.
• Preparation and maintenance
of reagents and volumetric solutions. Should have the knowledge on instrument
trouble shooting.
Desirable: 3 to 5 year working
experience API, post B.Sc./M.Sc. in Chemistry.
Location: Murthal, Sonipat.
Officer – Production
• Preferable candidate from
Bulk (Active Pharmaceutical Ingredients (API)
• Process handling to produce
the intermediate and API finish product.
• Perform the activity of Batch
to Batch Cleaning, Periodic Cleaning and change over cleaning of all equipment.
• Maintain housekeeping and
Cleanliness of plant.
• Handling of process within
EHS norms.
• Maintain the cGMP
Compliances.
Desirable: Minimum 01 to 02
years working experience post B.Sc./M.Sc./B.Pharma
Location: Murthal, Sonipat.
Officer – Regulatory Affairs
• Compilation, preparation, and
review of DMFs for US, Europe, Canada and ROW markets in specified eCTD or NeeS
or CTD formats.
• Setting specifications of API
process development, knowledge of litigations matter related to Drugs and
Cosmetics Act.
• Filing Annual updates and
Amendments to various regions of submitted DMFs.
• Handling queries obtained
from different regulatory agencies and customers.
• Compilation, preparation and
review of Technical Package of APIs.
• Compliance to audits of
regulatory bodies especially USFDA and EU.
• Generation of documents from
R&D, Production, QC and QA of newly developed APIs.
• Responsible for record
keeping and to ensure correctness of records pertaining to department.
• Responsible for all type of
computer work and follow-ups.
• Carrying out the initial
assessment of Vendor Questionnaire and relevant documents.
• To impart scheduled trainings
of ICH guidelines pertaining to department.
Desirable: Minimum 03to 05
years working experience B. Pharma/M. Pharma
Location: Murthal, Sonipat.
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