Prominent Consultant

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AGM - Quality Control (API)

15 - 25 Years

Vadodara


Job Description

- Handling complete in-process quality control and continuous improvement in process capabilities, managing quality across raw materials, work in progress, finished goods in various functional departments as per the standards
- Formulating standard operating & testing procedures & working standards for new processes / equipment's for ensuring environment, health & safety aspects and facilitating the technology transfer from laboratory to commercial
- Analyzing & assuring the quality of raw materials, intermediates and finished bulk drugs using modern analytical instruments - High Performance Liquid & Gas Chromatography
- Management of analysis of stability samples for Major Regulated markets.
- Review & Approval of Stability Protocols for Stability studies.
- Identifying the risk involved in the quality system and delivering solutions for the same
- Overseeing analytical instruments with respect to procurement, inventory management for the spares & chemicals service
- Preparing calendars and monitoring stability studies activities
- Interacting and coordinating with Regulatory Auditors like US-FDA, MHRA, WHO & EDQM during quality audits
- Maintaining all the documents pertaining to quality control as per the ISO & FDA requirements
- Imparting training to the new recruits in regards with the analytical methods & instruments
- Preparing & reviewing plan to ensure that all the regulatory & customer audits are within the compliance status
- Designing a schedule for internal audits and facilitating the process

Salary 10 Lac To 30 Lac P.A.
Industry Manufacturing / Production / Quality
Work Experience 15 - 25 Years
Qualification B.Pharma, B.Sc, M.Pharma, M.Sc

Key Skills

QC Quality Control API Bulk Drug Pharma Pharmaceuticals

Company Profile

Company Name

Client of Prominent Consultant

About Company Reputed API / Pharmaceutical Company of India
Email ID pranit@prominentconsultant.com

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