Madhu Instruments Pvt Ltd
Website:
madhuinstruments.com
Job details:
About us-Madhu Instruments Pvt Ltd (MIPL) manufactures high quality medical devices specializing in ophthalmology. Our commitment towards quality is paramount. With a proven track record of cutting-edge innovation and a reputation for adhering to the international best practices, quality compliance and reliability, we offer a myriad of ophthalmic devices to ensure best care for patients and hassle-free procedures for the doctors.
Responsibilities:● Lead Quality Control operations and ensure GMP, ISO, regulatory, and QMS compliance.
● Manage BPRs, specifications, test methods, sampling plans, SOPs, and quality documentation.
● Oversee raw material, packaging, in-process, and finished product testing, including chemical analysis.
● Plan and manage stability studies, equipment validation including IQ, OQ, PQ and laboratory activities.
● Handle deviations, non-conformances, product disposition, quality risks, and CAPA support.
● Lead, train, and develop the QC team and provide cross-functional technical support.
● Support CE, FDA, ISO, customer, and regulatory audits/inspections.
● Ensure laboratory quality systems, data integrity, and documentation compliance.
● Sterilization & Microbiology Expertise
● EO, Gamma & Steam Sterilization Validation – ISO 11135, ISO 11137 & ISO 17665.
● Cleanroom Qualification & Environmental Monitoring – ISO 14644.
● Bio burden & Sterility Testing – ISO 11737.
● BET/LAL & EO Residual – USP & ISO 10993-7:2026
Requirements:● 7-10 years of work experience in Quality Control in medical devices manufacturing unit.
● Excellent computer skills, including MS Office
● Strong communication skills, including the ability to explain and teach methodologies
● Understanding of medical device manufacturing methods and procedures
● Approved chemist (analytical or manufacturing)
● A confident and determined approach
● Excellent organizational & time management skills
● Team player
Qualification
B.Sc./B.tech/B.Pharma degree only, masters may be preferred.
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