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3+ years
Not Disclosed
10 Feb. 16, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Location: Dahej, India
Category: Quality Jobs
Company: CPL Pharmaceuticals Private Limited
Job Code: 18013769
Brand: Manufacturing - Dahej
Job Status: 1

Description:

• Ensure raw material, finished product, and intermediate sampling is conducted as per SOP.
• Ensure that every specification and method of analysis used corresponds to the correct product/material code.
• Ensure 100% implementation of analysis parameters as per the method of analysis.
• Follow instructions from the Shift/Section In-charge regarding analysis and planning.
• Report any laboratory deviations or discrepancies in analysis to the Shift/Section In-charge.
• Ensure completion of targeted analysis planning as per the schedule provided by the Shift/Section In-charge.
• Prepare working standards, IH, reference standards, and pharmacopoeial reference standards as per specifications and MOA.
• Calibrate laboratory instruments as per the scheduled timeline.
• Ensure all reagents and volumetric solutions are standardized as per schedule.
• Ensure analytical documents like specifications, protocols, and STPs are prepared as per SOP.
• Undergo training from the concerned person to update knowledge on cGLP systems and technical advancements.
• Conduct analyses and complete analytical reports/protocols as per product/material specifications.
• Maintain instrument logbooks properly as per analysis requirements.
• Seek training on cost reduction, technical awareness, and cGLP systems.
• Request training for workmen/trainees in areas where improvement is needed.
• Guide and train workmen, trainees, and contract workmen in QC laboratory operations.
• Coordinate with the QA department for cGLP system implementation.
• Coordinate with the production department for planning and clubbing of analyses.
• Coordinate with the store department for prior information on urgent raw material analysis.
• Coordinate with the EHS department regarding safety and environmental issues.