Assistant Manager | Quality Assurance

Roles & Responsibilities

• Need to write and author Quality Procedure related to BEP and BER
• Need to author the Biologic evaluation plan (BEP) in-line with ISO 10993 and USFDA requirements
• Identify and Qualify the right CRO to perform the required Chemical characterization (C.C) studies and Bio-compatibility studies for the devices developed/manufactured by HML
• Need to perform the risk assessment of the devices as per ISO 10993 and ISO 14971
• Need to write and author Biological Evaluation Report (BER)
• Need to update the relevant team members about the new regulatory requirements in the field of regulatory Toxicology of the Medical devices
• After publishing the New/Updated ISO standards (related to Medical devices Safety), need to perform the Gap analysis for the existed BER/BSA reports and remediate the same as per Global regulatory requirements
• Need to address the queries received from different MOH on submitted BEP/BER/Bio-data/C.C data.
• Responsible for management of CAPAs, Change Control, requalification of the CRO s and annual product safety review
• Work with SCM team to qualify the Critical supplier and service providing.
• Strong knowledge on OECD, ISO 13485:2016, ISO 10993 series, ISO 14971, EU-MDR, regional pharmacopeia, 21 CFR Part 58 Good Laboratory Practices.
• Responsible for planning and conducting internal audits.(In-line with all applicable regulatory requirements).
• Responsible for handling Quality projects assigned by the respective Reporting Manager .
• Responsible for assisting in the stability program for HML products, including the preparation or review of stability protocols and reports, loading and unloading of stability samples from the chamber, sending samples for testing, and performing required tests on stability study samples.
• Raising requests for generation of PR (Purchase Requisition), PO (Purchase Order), and GRN (Goods Receipt Note), and ensuring timely follow-up on payments to service providers from whom the respective services are availed.
• Responding to queries from Ministries of Health (MOH) and customers related to biocompatibility, chemical characterization, toxicological risk assessment (TRA), and degradation studies for HML products.
• Carrying or monitoring out in-vitro degradation studies for HML products, as and when required.
• Conducting audits of suppliers and service providers in accordance with ISO 13485 and ISO/IEC 17025 standards.
• Strict adherence to EHS policy and EHS procedures.

Qualifications

• Bachelor Degree / Post Graduate Degree in Science.
• 4 years experience in toxicology testing for medical devices