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Officer - Qa Loan Licensing (Contract Manufacturing)

3-6 years
Not Disclosed
10 Feb. 14, 2025
Job Description
Job Type: Full Time Education: B.Pharm/M.Pharm Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Officer - QA Loan Licensing (Contract Manufacturing)
Location: Nashik, India

Function: Quality Assurance
Job Posted On: 3 Days Ago

Job Description:

Educational Qualification:

  • B. Pharm / M. Pharm

Experience:

  • 03 - 06 years of experience in external preparations and Soft Gelatin Capsule IPQA and 3rd party activities.

Job Location:

  • Daman

Job Responsibilities:

  • To monitor all loan license and third-party activities at allotted CMO’s and ensure GMP compliance, regulations, and implementation of changes in process and product.
  • To check activities like dispensing, manufacturing, and packing.
  • Review batch documents and provide clearance for batch release for distribution.
  • To check and capture quality events at contract manufacturing sites and ensure compliance with corrective and preventive actions.
  • To monitor process validation, technology transfer activities, and QMS compliance at the site and arrange for reports.
  • To monitor the destruction of expired RM/PM/FP at the Loan License site.
  • Ensure and review the preparation of the annual product report for all Loan License products manufactured at the respective site.
  • Conduct periodic verification of control samples at the site and report any abnormal observations.
  • Ensure the availability of current valid master documents, including raw material, packing material, and finished product specifications, batch manufacturing records, and batch packing records at the site, along with the retrieval of obsolete documents.
  • Ensure GMP/GLP compliance at Loan License and third-party sites.
  • Review and monitor the production plan at sites.

Apply Here: Job Link

 

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