Title:  Manager - QC

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