Responsibilities:
1. Inspection & testing of incoming raw material as per specifications and prepare IAR (Incoming analysis report)
2. Inspection & testing of in-process material as per specifications and prepare inspection reports
3. Inspection & testing of finished products as per specifications and prepare inspection reports (certificate of analysis)
4. Verify BPR (Batch production records) and complete them by attaching required test reports.
5. Analysis of customer complaints related to quality issues and do the root cause analysis.
6. Documentation support of R & D projects related to quality control.
7. Inspection and preparation of records as per ISO & CE standards related to QC department.
8. Validation & calibration of various instruments & equipment used in production and QC.
9. Approval of all artworks (boxes, labels, IFUs etc) as per approved artworks.
10. Preparation of SOPs related to QC department and their implementation.
11. Preparation of documents and records for various audits - Drug department, ISO, CE & customer audits
12. Ensuring compliance of standards and processes within various departments related to QC.
13. Plan and conduct stability studies (accelerated & real time) of various devices and keep a record of the same.
14. Microbiology testing of product samples and environmental monitoring.
Requirements:
1. Work experience should be minimum 3-4 years in a medical device manufacturing organization.
2. Excellent computer skills, including MS Office
3. Strong communication skills, including the ability to explain and teach methodologies
4. Understanding of manufacturing methods and quality standards
5. Good at math and statistics
6. Strong problem-solving skills
7. A confident and determined approach
8. Excellent organizational & time management skills
9. Team player
Interested candidates can send their updated resume