Quality Assurance Manager

JobItUs; Dhule; On-site; INR 1,800,000 - 2,800,000; Full time

Job summary

JobItUs is seeking a Quality Assurance Manager for its starch-based pharmaceutical ingredients operations in India. The role focuses on ensuring cGMP compliance, managing QMS, validating processes, and preparing for regulatory inspections.

The ideal candidate brings 9–15 years of QA/QC experience in pharma, with at least 4 years in a managerial role related to starch powder or APIs, and holds MSc in Chemistry/Microbiology/Biochemistry or B.Tech in Chemical Engineering.

Qualifications

• 9–15 years of pharmaceutical QA/QC experience.
• Minimum 4 years in a managerial role in starch powder or API manufacturing.
• Postgraduate degree in Chemistry, Microbiology, Biochemistry or B.Tech in Chemical Engineering.

Responsibilities

• Maintain and update QMS SOPs, specifications and documentation for starch processing lines.
• Lead root cause analysis for deviations, OOS/OOT, and customer complaints.
• Implement CAPA and change control procedures to ensure continuous improvement.

Skills

QA leadership

cGMP expertise

Regulatory audits

Cross-functional coordination

Education

M.Sc. Chemistry

M.Sc. Microbiology

M.Sc. Biochemistry

B.Tech Chemical Engineering

Tools

IQ/OQ/PQ protocols

CAPA management

Job description

A Quality Assurance (QA) Manager for a Starch Powder Active Pharmaceutical Ingredient (API) or excipient manufacturing plant oversees cGMP compliance, quality management systems (QMS), process validations, and regulatory audits tailored to pharma-grade modified or native starches used as excipients/APIs.

• Job Title: Quality Assurance Manager
• Industry: Pharmaceutical API, Excipients & Starch Powder Manufacturing
• Reporting To: Head of Quality / Plant Head
• Experience Required:9 to15 years in pharmaceutical QA/QC, with at least 4 years in a managerial role handling starch powder or API manufacturing.
• Education: M.Sc. (Chemistry/Microbiology/Biochemistry) / B.Tech (Chemical Engineering).
• Location: Dhule Dondaicha MIDC Maharashtra.

Key Responsibilities

Quality Management System (QMS)

• Manage and update standard operating procedures (SOPs), specifications, and general documentation for starch processing lines.
• Oversee root cause analysis for deviations, out-of-specification (OOS), out-of-trend (OOT), and customer complaints.
• Implement robust Corrective and Preventive Actions (CAPA) and change control procedures.

Compliance & Regulatory Audits

• Ensure adherence to cGMP, ICH Q7 guidelines for APIs, and relevant ISO/IP/BP/USP compendial standards for pharmaceutical starch.
• Face and successfully manage regulatory inspections (USFDA, EDQM, WHO, or local FDA) and customer/third-party audits.
• Review and approve Annual Product Quality Reports (APQR) / Product Quality Review (PQR).

Validation & Operations Oversight

• Review and approve process validation, cleaning validation, equipment qualification (IQ/OQ/PQ), and computerized system validation protocols.
• Oversee line clearance, in-process quality assurance (IPQA), and final batch release of starch powder batches (moisture content, microbial limits, viscosity, purity tests).
• Monitor vendor qualification programs for raw corn/tapioca/potato raw materials and packaging components.

Required Skills & Competencies

• Deep technical knowledge of starch modification, physical-chemical testing, and microbial limit testing.
• Expertise in regulatory frameworks, audit handling, and risk assessment tools (HACCP/QRM).
• Strong leadership, cross-functional coordination, and written/verbal communication skills