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, recent 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.

📌 Executive - Corporate Quality Control (Mumbai)
🏢 Aristo pharmaceuticals
📍 Mumbai