Shree Umiya Surgical Pvt Ltd

QA Officer

Position: 1

Reports to: QA RA Executive

Job Location: Plot No.4002, GIDC Vatva, Ahmedabad

Qualification: M.Sc., B.Pharm

Experience: 1-4 years

Pay and perks: Best in the industry

Roles and Responsibilities

1. Must ensure the compliance of product and process with ISO-13485, CE and Regulatory standards.
2. Should have knowledge with updating the national, international guidelines and customer practices.
3. Responsible for maintaining the Product Technical documents.
4. Must have follow to prepare submission for product registration, license, variations, renewals, and certifications as per specific requirements.
5. Should have to verify and manage documents related to the QMS; including change control, investigation, deviation and CAPA, etc.
6. Responsible to face quality and regulatory audits.
7. Responsible to ensure the awareness of regulatory requirements throughout the organization.
8. Responsible to ensure the EU DOC and technical documentation is updated.
9. Responsible to ensure PMS & organize the MRM-IQA.
10. Responsible for planning and implementation of Internal Quality audits.
11. Responsible for liaison with Certification body / external body.
12. Responsible for liaison with external organization on matters related to the quality system.
13. Responsible to Control of Statutory & Regulatory requirement.
14. Responsible for the Issuance and control of the documents.
15. Document Change control.
16. Instrument Calibration verification.
17. Process Validation like sterilization, packaging, Sealing machine.
18. Training records maintain and provide. Training all departments.
19. Master list of documents, records, instruments, machines, distribution list.
20. Approved ETO sterilization cycle.
21. Check and verification document and record of sales, purchase, store, Production, QC and maintenance.
22. Preparation of SOPs and new record formats needed.
23. Random QC/QA inspection.

Prepared by Hemangini-HR