Officer - Corporate Quality Control

ARISTO PHARMACEUTICALS; Mumbai; On-site; INR 550,000 - 900,000; Full time

Job summary

ARISTO PHARMACEUTICALS is seeking an Officer Corporate Quality Control (CQC) to reinforce analytical quality systems across multiple sites. The role focuses on specifications management, procedures, and documentation under cGMP/GLP guidelines.

You will support AMV/AMT reviews, change controls, and CAPA tracking while coordinating with R&D and manufacturing for tech transfers and new product introductions. Strong regulatory awareness is essential.

Qualifications

• Experience with analytical quality systems and regulatory expectations.
• Proficient in review and management of QC documents and specs.
• Understanding of AMV/AMT procedures and changes.
• Knowledge of pharmacopeial requirements (IP/USP/BP/EP).
• Experience with CAPA, OOS/OOT investigations, and audits.

Responsibilities

• Support preparation, review, and management of analytical quality documents including Specifications, STPs, GTPs, Analytical Data Sheets, and test methods.
• Assist initiation and tracking of Change Controls for analytical specs and lab docs.
• Coordinate with R&D and manufacturing for product development and tech transfer related to analytics.
• Review AMV and AMT protocols and reports for compliance and accuracy.
• Monitor pharmacopeial updates and assess impact on procedures.
• Review QMS documents for effects on specs and analytical procedures.
• Support investigations into OOS, OOT, deviations, and discrepancies.
• Participate in internal/self-inspections and audits (regulatory, customer, vendor, third-party).
• Assist review of analytical docs related to MFC, MPC, PDR and new product files.
• Support CAPA implementation and tracking for analytical quality systems.

Skills

cGMP & GLP

Regulatory compliance

Documentation

Cross-functional coordination

Data integrity (ALCOA+)

Education

B.Pharm or equivalent

M.Pharm / MSc (Analytical Chemistry)

Tools

LIMS

Empower

SAP

ERP

eQMS

Job description

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.