Executive - Corporate Quality Control

We are looking for an experienced Executive - Corporate Quality Control (CQC) to join our Corporate Quality team and drive analytical quality systems, specification management, and regulatory compliance across multiple manufacturing sites.

Key Responsibilities

• Prepare, review, and approve Specifications, Standard Testing Procedures (STPs), General Testing Procedures (GTPs), Analytical Data Sheets, and other analytical quality documents.
• Initiate and manage Change Controls related to specifications, analytical methods, and laboratory documentation.
• Coordinate with R&D and manufacturing sites for new product development, product lifecycle changes, and technology transfer activities from an analytical quality perspective.
• Review Analytical Method Validation (AMV), Analytical Method Transfer (AMT), and related analytical documentation.
• Assess and implement pharmacopeial updates (USP, BP, EP, IP, etc.) and ensure timely compliance.
• Review Quality Management System (QMS) documents for impact on analytical specifications and testing procedures.
• Participate in investigations related to OOS, OOT, laboratory deviations, and analytical quality events.
• Support regulatory inspections, customer audits, and maintain inspection readiness.
• Participate in self-inspections, vendor audits, and third-party audits.
• Review and approve analytical sections of MFC, MPC, PDR, new product documentation, and related quality records.
• Monitor implementation of Global CAPAs impacting analytical specifications and laboratory documentation.

Desired Profile

• Qualification: B.Pharm M.Pharm M.Sc. (Chemistry, Analytical Chemistry, Pharmaceutical Chemistry, Microbiology, or related Life Sciences).
• Experience: 5-10 years in Quality Control, Corporate Quality Control, or Analytical Quality Systems within the pharmaceutical industry.
• Hands-on experience in specification management, analytical method validation/transfer, and laboratory documentation.
• Strong understanding of cGMP, GLP, ICH Guidelines, Data Integrity (ALCOA+), and pharmacopeial requirements.
• Exposure to regulated markets such as USFDA, EU GMP, MHRA, WHO-GMP, or PIC/S is preferred.
• Familiarity with LIMS, Empower, SAP, ERP, or eQMS is an advantage.
• Excellent analytical, documentation, communication, and cross-functional coordination skills.