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 to 15 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).

- Robust leadership, cross-functional coordination, and written/verbal communication skills

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📌 Quality Assurance Manager (Dhule)
🏢 Paradise Placement Consultancy
📍 Dhule