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Home / Job / 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

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.

TO APPLY CLICK HERE

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Allowed Type(s): .pdf, .doc, .docx

About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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