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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 QC - HPLC
Location: Manufacturing - API, Ankleshwar, Gujarat, India
Posted: Feb. 12, 2025
Employee Type: C-C8-Confirmed-HO Executive
Experience Range: Minimum 4 years

Job Responsibilities:

  • Handle HPLC systems with Chromeleon software and integration for testing.

  • Maintain instrument usage logs, inward registers, and training records.

  • Follow SOPs, specifications, and standard testing procedures (STPs) for In-process, Intermediate, Finished Product, Recovered Solvents, and Cleaning Samples.

  • Use LIMS for receiving samples with Intimation Slips for various test types (In-process, Intermediate, Finished Product, Recovered Solvents, Cleaning Samples, and outside samples).

  • Adhere to GMP and safety norms, following the company’s policies.

  • Attend internal and external training programs as per the schedule.

  • Perform timely analysis and hand over raw data to senior staff for review.

  • Report results promptly and investigate any deviations, Out-of-Spec (OOS) results, or incidents.

  • Maintain housekeeping and GLP (Good Laboratory Practices) in the working area.

  • Monitor temperature and humidity, and document related observations.

Requirements:

  • Total Experience: Minimum of 4 years in a relevant HPLC or QC role.

  • Skills: Proficiency in HPLC system operation, Chromeleon software, LIMS, SOPs, GMP, and data analysis.

This role involves direct work with sophisticated laboratory equipment and a focus on quality control testing and ensuring compliance with regulatory standards.