QA Manager
Job Description:
Management and control of activities pertaining to Quality Assurance.
Preparation of documents of QA and authorizing documents of other departments for regulatory compliance.
Preparation, review of quality manual, validation master plan.
Review of filled records of process and QC.
Co-ordination of activities related to Process department and quality control in connection with maintenance of overall quality of the products
Monitoring and control of established quality management systems and its documentation.
To organize and impart GMP training.
Organizing and coordinating in internal audit.
Organization of Validation activities and review and approval of their report
Coordinates in handling deviations, Change control, CAPA and its resolution and follow up.
Coordinates in handling nonconforming/rejected products and its resolution
Coordinating in complains and product recall activities resolution.
To Organize to Carry out assessment of Suppliers and approving them.
To prepare COA of Final Product Release.
In-Process Inspection and Final Testing as per testing procedure.
Final Inspection as per plan and Maintain non-conformance records for any discrepancy found.
Quality of products to be maintained without any rejection(s).
Analysis of data for In-Process and Final Inspection.
Identification & Traceability of all finished products.
Test Certificates, Manuals etc., to be sent to customers along with dispatch of the products.
Control of Monitoring and Measuring Devices
Maintaining records of Monitoring and Measuring devices and get it calibrated from time to time.
Identification & Traceability of the devices to be maintained.
Carry out any other job-related activities as and when deemed necessary.
The candidate should have an exposure of US CGMP and EMA
Interested candidates to share CV on hr@regrow.in
Management and control of activities pertaining to Quality Assurance.
Preparation of documents of QA and authorizing documents of other departments for regulatory compliance.
Preparation, review of quality manual, validation master plan.
Review of filled records of process and QC.
Co-ordination of activities related to Process department and quality control in connection with maintenance of overall quality of the products
Monitoring and control of established quality management systems and its documentation.
To organize and impart GMP training.
Organizing and coordinating in internal audit.
Organization of Validation activities and review and approval of their report
Coordinates in handling deviations, Change control, CAPA and its resolution and follow up.
Coordinates in handling nonconforming/rejected products and its resolution
Coordinating in complains and product recall activities resolution.
To Organize to Carry out assessment of Suppliers and approving them.
To prepare COA of Final Product Release.
In-Process Inspection and Final Testing as per testing procedure.
Final Inspection as per plan and Maintain non-conformance records for any discrepancy found.
Quality of products to be maintained without any rejection(s).
Analysis of data for In-Process and Final Inspection.
Identification & Traceability of all finished products.
Test Certificates, Manuals etc., to be sent to customers along with dispatch of the products.
Control of Monitoring and Measuring Devices
Maintaining records of Monitoring and Measuring devices and get it calibrated from time to time.
Identification & Traceability of the devices to be maintained.
Carry out any other job-related activities as and when deemed necessary.
The candidate should have an exposure of US CGMP and EMA
Interested candidates to share CV on hr@regrow.in
Salary: INR 3,00,000 - 7,00,000 P.A.
Industry:Pharma / Biotech / Clinical Research
Functional Area:IT Software - QA & Testing
Role Category:QA/Testing/Documentation
Role:Quality Assurance/Quality Control Manager
Employment Type:Permanent Job, Full Time
Keyskills
Desired Candidate Profile
Education-
UG:Any Graduate - Any Specialization, B.Sc - Any Specialization
Company Profile
Regrow Biosciences Private Limited
We are a leading biotechnology company focused at delivering the most advanced cell therapy treatments. We are the pioneers of regenerative medicines in India and we aim at improving the Indian healthcare scenario.
Our Vision
To become the world's largest stem cell based tissue and organ development factory.
Our Mission
Improving human healthcare by innovating and delivering regenerative medicine based healthcare solutions.
Our Belief
There certainly is no replacement for what nature has endowed upon us very much like cartilage and bone. At REGROWâ„¢, we align ourselves to the nature and rebuild people's lives by regenerating cells.
Our dedicated focus on biotechnology since our foundation in 2009 and our state-of-the-art technology has led to the development and approval of World's first autologous bone cell therapy product OSSGROWâ„¢ and India's first autologous cartilage cell therapy product CARTIGROWâ„¢
Our Vision
To become the world's largest stem cell based tissue and organ development factory.
Our Mission
Improving human healthcare by innovating and delivering regenerative medicine based healthcare solutions.
Our Belief
There certainly is no replacement for what nature has endowed upon us very much like cartilage and bone. At REGROWâ„¢, we align ourselves to the nature and rebuild people's lives by regenerating cells.
Our dedicated focus on biotechnology since our foundation in 2009 and our state-of-the-art technology has led to the development and approval of World's first autologous bone cell therapy product OSSGROWâ„¢ and India's first autologous cartilage cell therapy product CARTIGROWâ„¢
View Contact Details+
Recruiter Name:Ms. Chaitali
Contact Company:Regrow Biosciences Private Limited
Telephone:91-22-67330300
Address :2 ABC, ACME PLAZA, 2nd FLOOR, Andheri Kurla Road