Job Description :

Key responsibilities will include (but are not limited to) the following:

- Ensuring the Compliance with Standard Testing Procedure and specifications.

- Implementation and continuous improvement of the Quality Management System in order to ensure current regulatory requirements

- Manage a team of Quality Engineers in support of new product development

- Preparation and implementation of internal policies and SOPs

- Provide guidance and participate where appropriate in Feasibility, Development, Design Verification, Design Validation, Design Transfer, and Commercialization reviews and activities from a quality and documentation perspective.

- Handling of non-conformities and CAPAs, ensuring their adequate and timely closure

- Support audit readiness (ISO 13485 and FDA 21 CFR 820)

- Conducting internal audits (Self inspections and supplier audits)

- Draft and negotiation of Quality Agreements

- Review and formal approval of technical reports

- Providing internal and external (QMS) trainings and coaching

- Strong knowledge of European and US regulations, guidelines and standards such as ISO 13485, EC Directive 93/42/EEC, FDA 21CFR part 11, ISO 9001, ICH etc.

- Assesses changes in existing products to and determines the need for new / revised licenses or registrations.

Desired Candidate Profile:

- Review and approving of quality related documentation as per USFDA 21 CFR 820/ISO 13485 2016

- Implementation of QA programme as per USFDA 21CFR 820/ISO 13485 2016

- Monitoring all QA/QC activities and Proactive Quality improvements for preparation of USFDA 510 K for PTCA Catheters and be a part USFDA PROJECT team.

- Implementation of ISO 13485 : 2016

- Monitoring the inspection of the material from raw material stage to final product stage.

- Monitoring the in-process quality control check of the product at various production stages

- Review and approving of quality related documentation, Records, SOP's and STP- s

BE/M. Pharmacy - Pharmaceutics/Pharmacology/Analytical Chemistry with minimum 10yrs of experience.

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