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 recent 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.

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