Job Description
Title: Manager - QC
Custom Field 2: 2872
Location:
Bavla, Gujarat, IN
Country/Region: IN
State: Guja
City: Bavla
Company: Dishman Carbogen Amcis Limited
Business Unit: General
Travel
Description:
Technical Expertise
Strong understanding of analytical method validation principles and regulatory guidelines (ICH Q2(R1), USP, etc.)
Proficiency In Analytical Techniques
HPLC (High-Performance Liquid Chromatography)
GC (Gas Chromatography)
FT-IR
UV-Visible Spectroscopy
ICP-MS (Inductively Coupled Plasma Mass Spectrometry)
GC-MS (Gas Chromatography-Mass Spectrometry)
Regulatory Compliance
Experience in preparing and reviewing validation protocols and reports
Familiarity with global regulatory requirements (FDA, EDQM, ANVISA, PDMA, etc.)
Exposure to regulatory audits and inspections
Documentation & Quality Systems
Good documentation practices (GDP)
Knowledge of laboratory quality systems and data integrity requirements
Experience With LIMS Or Other Lab Data Management Systems
Problem Solving & Troubleshooting
Ability to troubleshoot analytical methods and instrumentation issues
Root cause analysis and CAPA implementation
Project & Team Management
Experience in handling method validation projects independently
Ability to manage and mentor a team of at least 15 members
Communication & Collaboration
Effective communication with cross-functional teams (R&D, QA, RA)
Ability to present findings and defend validation data during audits
Additional Skills (Preferred)
Exposure to method development and transfer activities.
Experience with other regulatory bodies (e.g., TGA, MHRA, WHO) is an added advantage
Job Segment: Compliance, Data Management, Quality Manager, Law, Quality, Legal, Data
