1] QA/RA Executive -1We are currently required a BSC/MSC in with an excellent Medical device knowledge.
Salary: 35 k to 45 k
Location: IMT Faridabad Plant
Experience: 4 to 5 years
Former experience in the following:
Working in Medical Device: Initiate, monitor, and verify the effective implementation of the Quality Management System in all areas of company activities
Regulatory submissions: Regulations requirements of the ISO 13485; FDA; CE (MDD/MDR) and MEDDEV
Composing and maintaining quality manual procedures (i.e., SOP's), Follow the requirements of GLP/GMP.
Internal and external audits, inspections.
The following skills and abilities are advantageous:
Computer skills with ERP (Priority) and ALM (Orcanos) systems.
Fluently verbal and written English.
Able to quickly learn and apply new concepts.
High ability to work independently.
Self-motivated and proactive.
Planning, organizational and administrative abilities.
Good interpersonal skills.
Technical skills.
Submission Application Online & Offline in According MDR 2017 in CDSCO India
Preparation Compliance document for CDSCO
Documentation, SOP & protocol preparation for various activity
Implementing the ISO 13485:2016 and Other Internal standard in company.
Label Approval, Issue COA, Approval of BMR etc.
Calibration of Equipment& Validation of Clean room
Equipment CIP, Hygiene & pest control monitoring in factory
Shelf life assignment of new product & analysis of samples
Preparation and standardization of volumetric standard solution
Implementation and management of all QA activities which includes:
Quality System Tools administration, training and auditing [as Customer Complaints/CAPA/Training/Control Documents/Standards].
Verify the compliance of quality procedures and working instructions with predefined and new mandatory standards.
Ensure that the Company's quality assurance and control system complies with the procedures and working instructions through audits, training, preventive and corrective actions.
Maintaining the training, qualification, and certification records of Company personnel including developing, determine and conduct training and certification subject to the Quality Manual.
Approve / disapprove suppliers and vendors of goods and services subjected to the Quality Manual.
Approve / disapprove facilities, equipment, processes, and materials subjected to the Quality Manual.
Regulatory submissions in various countries.
Regulations requirements support to all areas of company activities.
Define and conduct tests, bench tests and experiments to support regulatory requirements.
Marketing, Social media material and labeling review & approval.
Job Types: Full-time, Permanent
Pay: 35,
- 00 - 45,000.00 per month
Benefits: - Health insurance
Provident Fund
Schedule:
Supplemental Pay:
Education:
Experience:
- total work: 4 years (Preferred)
Work Location: In person
