Complain Management/ Complains Investigation/ QMS/ GMP/ Pharmaceutical

2 - 5 years

4 - 7 Lacs

Posted:3 months ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

Dear Applicants, Greetings from Teamware Solutions! Position: Complains Management Experience: 2- 5 years Notice Period: Immediate Joiners Location: Bangalore, Pune, Gurugram, Noida Interested candidates can apply to the given Email ID : greeshma.t@twsol.com Role & responsibilities 1. Utilize deep knowledge of medical devices Quality Management Systems (QMS ), for key processes like post-market surveillance, complaint handling, and eMDR filing . 2. Complaint Investigation and Resolution : Support comprehensive complaint investigations and ensure timely resolution and follow-up 3. Manage quality events related to audit observations, ensuring readiness for regulatory audits such as those by USFDA, Health Canada, ANVISA, TGA, etc. 4. Address compliance requirements and ensure the quality systems meet regulatory standards 5. Ensure accurate and consistent coding of medical device complaints to facilitate effective tracking and resolution. 6. Collaborate with regulatory and clinical teams to maintain coding standards and improve the accuracy of device categorization Preferred candidate profile 1. In depth knowledge of Quality/QMS, and Medical Device Reporting related to pharmaceuticals/devices within Life Sciences Industry. 2. Experienced in utilizing extensive knowledge of medical devices QMS for crucial processes, including post-market surveillance, complaint handling, and eMDR filing 3. Proven track record in supporting comprehensive complaint investigations, ensuring timely resolutions and effective follow-up 4. Experienced in ensuring accurate and consistent coding of medical device complaints to facilitate effective tracking and resolution

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Teamware Solutions

IT Services and IT Consulting

Chennai Tamilnadu

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