WS Area Specialist I

201920202022Kincentric

At Novo Nordisk we recognise that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and the communities we operate in. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We are happy to discuss flexible working, depending on the role and subject to business needs.

&&&PSQIT&

.60

Fill & Finish Expansions is a newly established and growing area with the responsibility to design, plan and build all major fill & finish expansion projects across Product Supply, Quality & IT to serve the needs of millions of patients. We do it by rethinking our fill & finish facilities with the use of modern technology. We are setting the standards for the facilities of the future, designing facilities we will still be proud of 20 years from now.

As a part of that, Fill & Finish Expansion Site Tianjin is located at No. 60, Muning Road in TEDA, adjacent to the current manufacturing site. Here, you will be working with multiple sites and cultures across the world to join efforts to drive changes and improve the lives of patients with diabetes and other chronic diseases.

Apply now if you wish to be a part of this exciting global program in Novo Nordisk!

Qualifications (minimum requirements)

Education Background:

. Bachelor Degree and above in mechanical engineering, industrial engineering, electrical engineering, chemistry, pharmacy, bioscience, computer science or similar education background.

. Education/training of cGMP is preferable. cGMP

. Fluent in reading, written and spoken English. Professional Experience:

. Minim 10 years of relevant working experience. Minim 5 years of production experience in aseptic process of cGMP regulated pharmaceutical industry or in life science industry. 105cGMP

. Knowledge and experience on cGMP or GMP manufacturing process validation/qualification. cGMPGMP

. Strong knowledge and experience in cleaning and sterilization process and related equipment.

. Experience of working in cross function team environment.

. Strong documentation and Audit experience.

Job content

Key areas of responsibility :

WS Area Specialist is Technical Lead of WS process during project execution, ensuring good design of process and equipment fit for the future production demand. Ensuring SRV implementation product quality and compliance, prepare for audit readiness and execution, validation and revalidation. The position plays an important role in cGEP and cGMP, and continuously improving standards in operation process.

Main Job Tasks :

SRV/Science- and Risk-based validation

. Design, plan, lead and carry out initial validation, establish validation state in compliance with regulatory and NN requirements on time.

NN

. Design and carry out experiment or justification (CDS, PJ etc.) to find process operational parameter range to ensure stable production

CDSPJ

. Write validation related documents with high quality, including VPL, FAT/SAT, IV/OV/PfV plan/report, SE, VSS, TMX, etc.

VPL, FAT/SAT, IV/OV/PfV plan/report, SE, VSS, TMX, etc.

. Plan and carry out re-validation with shortest stop for production and write high quality validation documentation.

. Drive Investigation of Validation Deviation, minimize impact on validation activity and make corrective/preventive actions

/

Compliance and Quality System related task :

. Maintenance the compliance between authority and NN requirement, also between the global standard and local SOPs. //

. Well prepare for audit in order to obtain high rating in NN internal audit and pass all inspection from authorities. Be the owner of audit/inspection finding action. NN

. Drive investigation of DVs/ICs/CCs based on SPS, minimize impact on production and product release and make corrective/preventive actions

SPS///

. Be responsible and write CR, ensure sufficient stakeholder involvement and evaluation, complete change on time.

. Be responsible and write process and compliance related reports including SOP, APR, QMR, QRM, Trend reports etc.

SOP, APR, QMR, QRM,

. Monitor the process trending.

Lead and drive process optimization and improvement.

. Lead and coach improvement activities, improvement of standards within assigned process.

. Participate in event response activities using SPS method, establishing cause and effect relationships that determine root causes. Leverage solution, best practices and benefits to process group through business case.

. Ensure anchoring of process improvement projects.

. Develop training and Train the trainer in production support team.

Technical Lead and competence development for the team

. Be acuminous to the front technology and regulation, drive concept design and set technical direction to ensure STJ has sufficient technical solution to full fill business needs. Have high influence in IFP global technical group.

STJIFP

. Direct handling complicated problem (drive team when necessary) with systematic approach and clear report.

. Develop and coach other engineers.

Other individual assignments :

. Incorporate Novo Nordisk Way (NNW) into daily way of working NNW

. Other work assigned by line manager.

. Keep line manager accurately informed of work status as well as any problems

. The position needs oversea travel under business need

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing.