Cellbios Healthcare & Lifesciences Private Limited Hiring 2022 . Cellbios Healthcare & Lifesciences Private Limited Notification full details below.Interested and eligible candidates can Apply Now.CellBios is the largest medical device manufacturing company, offers various products and medical solutions for biotechnology and medical industry. All medical devices are manufactured under GMP, ISO 13485:2016 and as per the Medical Device Rule, 2017.
Vacancy details:
- Post Name: Quality Assurance & Regulatory for Medical Devices /Quality Control Executive
- Qualification: B.E/ B. tech in biomedical engineering / Biotechnology/MSc – Chemistry /B. Pharm
- Experienced: 02 to 5 years
Job Description: Greeting from Cellbios Healthcare & Lifesciences Private Limited !!!!
Important Details :
- Post of date:20/10/2022
- Location: Hyderabad, India
- Selection Process: The selection will be on the basis of Interview.
- Mode of Interview: Face to Face
- Interview Rounds of Interview: HR
Roles:
To work in Quality Control activities of the Lab with regard to Testing of Raw Material, In process, Finished Products, documentation and quality management system requirements at Quality Control lab. To ensure that the requirements of MDR, ISO 13485, ISO 3826, USFDA QSR – CFR Part 820 and such other international standards are implemented and maintained. Handle regulatory and customer audits and customer requirements related quality and other statue.
Responsibilities:
- Ensure all phases of a manufacturing and other handling process meets the standards or requirements of the quality plan including in-process check.
- Play an active role in all stages of the production process (Raw Materials Analyst), during production itself (In Process Analyst) or at the end of manufacture (Finished Product testing).
- Timely completion of all experiments according to established Standard Operating Practices (SOPs), and also Good Laboratory Practices (GLP) or Good Clinical Practices (GCP), ISO/ EN standards for highly regulated industries.
- Basic lab-work and use of chemical/pharma/microbiology testing equipment and processes.
- Prepare technical documents that report the results of their lab work. (Batch release records, sterility data, stability data, validation data)
- Responsible for minor equipment troubleshooting, calibration and repair.
- Establish specifications for conducting assays and writing standard operating procedures.
- Follow practices/ documentation pertaining to MDR and all applicable statutory requirements
- Responsible for QMS elements viz. Change control, Deviation, CAPA etc. and its tracking for closure.
- Monitoring of supplier performance/ compliance documents (Audit response/CAPA) and support the team in taking informed decision on approving the supplier/vendor/service providers
Qualifications and Skills Necessary:
- Master’s degree or equivalent (or higher) in chemistry/ plastic engineering/ polymer science/ microbiology or Biotechnology.
- Ability to work both in a team or individually and good mathematical skills are all required.
- Proven knowledge of methods/techniques of medical devices. ISO 3826
- Experience in Medical devices QMS ISO 13485 and wet lab/ instrumentation.
- Hands on experience in EN-ISO 13485, EU MDR, CE marking, USFDA QSR – CFR Part 820 and such other international standards.
- Experience in handling audits/ inspection of Indian medical devices rule requirements.
Send your resume to hr@ellbios.com
Quality Assurance & Regulatory for Medical Devices (Cell therapy / Bioprocess / BMT)
Job opening for Executive / Sr. Executive / Asst. Manager / Manager for Quality Assurance (QA) & Regulatory for Medical Devices
Education: B.E/ B. tech in biomedical engineering / Biotechnology/MSc – Chemistry /B. Pharm
Location: Chennai
The ideal candidate is a critical thinker who will proactively improve the quality systems of the company through internal audits, participation in process improvement programs, and interaction with regulatory affairs.
Roles and Responsibilities:
- Writing Technical documents, carrying out Literature survey, review, data extraction and data analysis for new medical device products.
- Conduct Technical Review for Manufacturing and Quality Documents in compliance with Regulatory standards Good Manufacturing Practice, EU MDR Regulation 2017/745, USFDA, MDSAP and India MDR
- Creation and updating validation Protocols and Reports (Product/ Packaging Design verification & Validation and Adoption activities)
- Preparation for protocols and procedures, during development phase as well as manufacturing and post-marketing surveillance studies. Clinical evaluation studies.
- Risk assessment, benefit analysis and risk management as per ISO 14971
- To perform detailed assessment on Medical Products including Package failure analysis.
- Handling audits related to State FDA, CDSCO, CE Marking, US FDA 510K, MDSAP and Notify body for QMS/ MDR.
Experience:
- Quality assurance/ Regulatory affairs experience: 5 years exp. in writing technical documentation’ role in medical devices preferred.
- Good knowledge on Medical Devices Rules and BPSA.
- Experience with ISO13485, 21 CFR Part 820, EU MDR and other regulatory requirements associated with medical devices
- Training on ISO 13485:2016, MDR & ISO 14971 -Risk Management.
Send your resume to: hr@cellbios.com
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