QSR Auditor (New Delhi)

JOB SUMMARY :

Under direct supervision, audit Medline suppliers’ quality management system per applicable regulations

CORE JOB RESPONSIBILITIES :

1) Audit Medline Asia suppliers per Medline internal audit SOP and applicable regulations as ISO 13485, FDA regulations, QSR part 820, MDR 2017 / 745, ISO9001, ASTM standards and etc.

2) Prepare Audit reports post audit as a part of Audit Compliance & also perform pre- assessment audit support. Draft and publish audit reports in high quality and timely.

3) Conduct adequate CAPA follow-up and evidence review for supplier in a timely manner

4) Provide supports and guidance for vendors in improving the quality management system per Medline internal audit SOP and applicable regulations as ISO 13485, FDA regulations, QSR part 820, MDR 2017 / 745, ISO9001, ASTM standards and etc..

• Response to vendors’ questions;
• Necessary instruction, guidance and training for suppliers;

Others

5) Support pre audit and support vendors on 3rd party audit project assigned by supervisor / manager

Support to conduct pre audit

Support to follow-up with vendors to address the problems identified during the audits

(Support vendor on CAPA review

6) Other assignments related to Quality Management System, supplier audit or assigned by Manager

EDUCATION :

Pharmacy / M. Pharmacy, Life science background, B.Tech / M.Tech. M Pharma OR Biotech / Bio Medical Engineering.

CERTIFICATION :

BSI (or equivalent) ISO 13485 : 2016 certification.

RELEVANT WORK EXPERIENCE

At least 2+ years of experience on quality audit.

Third-party medical device auditor, or quality system personnel in a foreign-funded enterprise medical device company, or SQE (Supplier Quality Engineer) who is responsible for suppler audit in a foreign-funded enterprise.

Having experience in drug, cosmetic, or laboratory audits will be considered a plus.

ADDITIONAL :

Willing to travel up to 50% of the time for business purposes (domestically and internationally).

Fluent both in written and verbal English.

Experience processing all relevant details, understanding and prioritizing their importance and drawing clear and concise conclusions.

Solid knowledge of ISO 13485, FDA regulations like ICH Q7, 21 CFR 210 & 211, ISO 22716, QSR part 820, MDR 2017 / 745, ISO9001, ASTM standards and etc.

Strong time management skills. Ability to manage multiple assignments.

Good reporting and presentation skills

Good communication and cooperation skills

Familiar with general office software.