Quality Assurance Manager
1 Nos.
43205
Full Time
9.0 Year(s) To 15.0 Year(s)
10.00 LPA TO 14.00 LPA
Production / Quality / Maintenance
Pharma/Biotech/Clinical Research
B.Sc - Chemistry; M.Sc / MS Science - Chemistry; M.Sc / MS Science - Organic Chemistry
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).
- Strong leadership, cross-functional coordination, and written/verbal communication skills
For more details call 9765567505
Company Profile
The Company Has achieved remarkable milestones during the history of the last 30 years since its incorporation in 1973. The Company has successfully enhanced the production capacity of Maize Refining from 60 MT to 400 MT per day. The product range has been also successfully expanded to cater to the requirements of Food, Pharmaceutical, Textile, Paper & Adhesive industries.
Telephonic Interview Available
- Telephonic interview are scheduled for this job opening.
- Interested Candidates are requested to apply and get recruiter contact number for telephonic interview.
- Candidates can call recruiter on given contact to start telephonic interview during working hours.