QA RA Executive

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

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

Prepared by Hemangini-HR