Quality Assurance (QA) Assistant Manager

JobItUs; Dhule; On-site; INR 1,400,000 - 2,100,000; Full time

Job summary

JobItUs in Dhule, Maharashtra, seeks an Assistant Manager - Quality Assurance to lead cGMP compliance, QMS documentation, and audits for starch derivatives used in pharma and food grades.

The role involves working with production, QC, and warehouse teams to approve records, manage deviations and CAPA, and ensure product quality across IP/BP/USP standards.

Qualifications

• M.Sc. in Organic Chemistry
• M.Sc. in Biochemistry
• M.Sc. in Life Sciences
• 5–9 years QA experience in chemical/food/API manufacturing
• Experience with cGMP and regulatory audits

Responsibilities

• Maintain and update QMS in line with cGMP, ISO, IP/BP/USP for starch derivatives.
• Review SOPs, BMRs, and analytical records for accuracy and compliance.
• Coordinate internal, customer, and regulatory audits; manage CAPA (Corrective and Preventive Actions).
• Coordinate with Production, QC, and Warehouse for material sign-offs and final product disposition.

Job description

A Quality Assurance (QA) Assistant Manager for a starch powder or pharmaceutical/food-grade starch active/derivative manufacturing plant in the Dhule/Dondaicha MIDC region oversees cGMP compliance, QMS documentation, process validation, and regulatory audits for specialized grades (IP, BP, USP).

Job Profile & Core Details

• Position Title: Assistant Manager - Quality Assurance (QA)
• Industry Segment: Starch Powder / Food & Pharma Grade Derivatives / API Manufacturing
• Location: Dondaicha MIDC, Dhule District, Maharashtra
• Education Requirement: M.Sc. (Organic Chemistry / Biochemistry / Life Sciences)
• Experience Range: 5 to 9 years of relevant QA experience in a chemical, food, or API manufacturing environment

Key Responsibilities

• Quality Management Systems (QMS) & Compliance:
  • Maintain and update QMS in line with cGMP, ISO, and relevant Pharmacopeia standards (IP/BP/USP) for starch derivatives.
  • Review and approve Standard Operating Procedures (SOPs), Batch Manufacturing Records (BMR), and analytical records.
  • Handle Market Complaints, Deviations, Change Controls, and CAPA (Corrective and Preventive Actions).
• Shop Floor & In-Process QA (IPQA):
  • Monitor line clearances and oversee clean-room packaging environments managed via automated PLC/SCADA systems.
  • Ensure strict compliance with Good Documentation Practices (GDP) across manufacturing blocks.
• Validation & Audits:
  • Coordinate equipment qualification (IQ/OQ/PQ), process validation, and cleaning validation protocols.
  • Face and manage internal audits, customer audits, and regulatory inspections.
• Cross-Functional Coordination:
  • Work closely with Production, Quality Control (QC), and Warehouse teams for material sign-offs, line approvals, and final product disposition