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

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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