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Ztmp Qa Of Qc

Zydus Healthcare Limited
Zydus Healthcare Limited
4+ years
Not Disclosed
10 Feb. 17, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Job Title: ZTMP QA of QC
Location: Manufacturing - API, Ankleshwar, Gujarat, India
Posted: Feb. 12, 2025
Employee Type: C-C8-Confirmed-HO Executive
Experience Range: Minimum 4 years
Preferred Background: Quality Control

Job Responsibilities:

  • Ensure Good Laboratory Practices (GLP) and compliance with QC SOP.

  • Review and approve analytical reports for intermediates, drug substances, stability reports, stability protocols, trends, and instrument calibration.

  • Review and approve stability and API analytical reports.

  • Review and approve working, reference standards, and certificates of analysis (COA).

  • Handle the issuance and retrieval of controlled documents related to QC.

  • Review audit trails in laboratory software.

  • Review user access privileges of instruments and ensure compliance.

  • Coordinate and provide documents for Drug Master File (DMF) filings.

  • Review specifications and standard testing procedures.

  • Oversee the calibration of laboratory instruments and equipment.

  • Participate in technology transfer and related activities.

  • Review stability summary trends and risk assessment reports.

Requirements:

  • Total Experience: Minimum of 4 years

  • Preferred Background: Experience in the Quality Control department.

  • Key Skills: Knowledge of GLP, QC SOP compliance, analytical reports, stability protocols, calibration processes, and DMF filings.

This position offers an opportunity to work in a critical quality assurance role in a regulated manufacturing environment, ensuring compliance and the integrity of laboratory processes.