Location
Pune | India
Job description
Be part of something altogether life-changing!
Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.
At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients. With associates across 40+ countries, Cytiva is a place where every day is a learning opportunity – so you can grow your career and expand your skills in the long term.
Forming part of the Biotechnology segment at Danaher, we bring together dedicated technical expertise and talent to develop the next generation of life-changing therapeutics.
In this role, you will have the opportunity to: - Creation and review of complete technical documentation and to Co-ordinate with cross-functional teams for qualification documents for all projects:
- Entry of new project into Vault and management of the complete Project structure through Vault database.
- Inspection of Incoming component specifications with respect to the approved Component List.
- Review of all supplier certification (MOC, Calibration etc) and documentation with respect to requirement/standards.
- To coordinate with Supplier for on time delivery of pending documents.
- Preparation and review of Operating Manuals.
- Performing and supporting cross functional team in the Documentation check during Pre-FAT and FAT.
The essential requirements of the job include: - Responsible for review of Scanning and storage of technical documentation in Vault server along with the system pictures.
- To co-ordinate with Supplier for system pictures and ensure for its proper storage as per process
- To ensure that the validation package is dispatched along with the system.
- Supporting the PE/PM/Service team in smooth closure of any open punch points observed during Pre-FAT/FAT/SAT within time.
- Maintaining the in-house calibration record and plan for on time calibration for the same
- Maintaining the ISO procedures and formats as stated in the Documentation procedure
- Maintaining the Visual Daily Management for the Department and actively participating in raising and closure of the issues through various improvement tools as defined by the organization
It would be a plus if you also possess previous experience in: 4+ years of experience in Validation/Documentation in Biopharma and or Biotech Industry.
Knowledge of ASME-BPE, ISPE, cGMP, GDP.
Eye for Detail, good communication skills, multitasking, ability to take up challenges with positive attitude.
At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what's next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit
At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
Job tags
Salary
