Officer - Corporate Quality Control

We are looking for a Officer Corporate Quality Control (CQC) to support analytical quality systems, specification management, regulatory compliance, and quality improvement initiatives across multiple manufacturing sites.

Key Responsibilities

• Support preparation, review, and management of analytical quality documents including:
1. Specifications
2. Standard Testing Procedures (STPs)
3. General Testing Procedures (GTPs)
4. Analytical Data Sheets
5. Test Methods and related QC documents
• Support initiation and implementation of Change Controls related to analytical specifications, procedures, and laboratory documentation.
• Coordinate with R&D and manufacturing sites for new product development and technology transfer activities related to analytical requirements.
• Support review of Analytical Method Validation (AMV) and Analytical Method Transfer (AMT) protocols and reports.
• Monitor pharmacopeial updates (IP, USP, BP, EP, JP) and support impact assessment and implementation.
• Review QMS documents for impact on specifications and analytical procedures.
• Support investigations related to OOS, OOT, laboratory deviations, and analytical discrepancies.
• Participate in Self-Inspections, regulatory audits, customer audits, vendor audits, and third-party audits.
• Support review of analytical documents related to MFC, MPC, PDR, and new product documentation.
• Support implementation and tracking of CAPAs related to analytical quality systems.

Desired Profile

• Qualification: B.Pharm M.Pharm M.Sc. (Chemistry Analytical Chemistry Pharmaceutical Chemistry Life Sciences).
• Experience: 2-6 years of experience in Quality Control, Analytical Quality Assurance, or Corporate Quality Control in the pharmaceutical industry.
• Good understanding of:
1. cGMP & GLP requirements
2. ICH Guidelines
3. Data Integrity (ALCOA+)
4. Analytical Method Validation & Transfer
5. Change Control, CAPA, OOS/OOT, and Quality Systems
6. Pharmacopeial requirements (IP/USP/BP/EP)
• Experience with QC documentation review and regulatory compliance activities.
• Knowledge of LIMS, Empower, SAP, ERP, or eQMS will be an added advantage.
• Good communication, documentation, and coordination skills.