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.

Re

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