Quality Validation Consultant - Lab Information Systems

NNIT A/S

Fuldtidsjob
Udlandet (øvrige)

NNIT is one of the world’s leading consultancies in IT development, implementation and operations serving the Life Science industry for over 20 years. We have applied the latest advances in technology to make software development, business processes and communication significantly more effective for our clients, some of the leading pharmaceutical, biotech, and medical device companies in the industry.

NNIT has grown by more than 1,000 people globally over the last four years globally, is in the process of rapidly expanding their US Operations, and has a number of exciting opportunities. NNIT’s unique culture and approach to business is quickly making NNIT an employer of choice in the US.

We believe “happy employees create happy customers” and has created one of the most unique employee cultures in the industry that offers world-class benefits and numerous opportunities for career growth and advancement. Find out what about the exciting new opportunities NNIT has to offer today!

Quality Validation Consultant – Lab Information Systems (LIS)

We are currently seeking an experienced and dedicated Quality Consultant to work onsite with our biopharmaceutical client located in the San Francisco area for a Quality Consultant to lead Lab Information Systems validation and quality project.

Daily responsibility will involve deviation investigation and technical authoring, CAPA authoring to record approvals, CAPA record closure authoring, miscellaneous. technical authoring (SOPs, work instructions, etc.) and benefits realization analysis on tasks (typically change management records) assigned by client.

This person will working in the laboratory instruments and lab information systems areas leading and implementing validation strategies and authoring validation summary reports. This will involve working within the software development process and IT infrastructure related to systems such as VMWare, databases, and networking components. This person will identify efficient testing approaches that provide pragmatic risk-appropriate coverage for the client. Leading investigation meetings involving stakeholders with a wide range of technical expertise and seniority will also be a key responsibility.

Requirements

Must Have:

5-10 years of computer systems validation experience

2+ years of working with laboratory instruments and lab information systems.

Experienced in leading developing and implementing validation strategies and authoring validation summary reports (where we verify step-by-step that the plan was followed).

Demonstrable knowledge of the software development process and IT infrastructure… (familiarity with VMWare, databases, and networking components).

A refined understanding of computer systems testing- being able to identify efficient testing approaches that provide pragmatic risk-appropriate coverage.

Excellent written and spoken communication skills- (ability to pass the NNIT technical writing assessment).

Ability to lead investigation meetings involving stakeholders with a wide range of technical expertise and seniority.

The ability to work without close supervision to tight deadlines- meeting all quality and schedule requirements.

Preferred:

1+ years of IT quality assurance experience providing review and approval of validation deliverables in the pharmaceutical industry.

CANDIDATES CAN WORK AS A W-2 SALARIED EMPOLOYEE OF NNIT WITH FULL BENEFITS OR AS A 1099 CONSULTANT.

CANDIDATES MUST BE AUTHORIZED TO WORK IN THE US ON A FULL TIME BASIS. NO VISA SPONSORSHIP AVAILABLE FOR THIS POSITION


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Fuldtidsjob
Udlandet (øvrige)
IT
Kemi, Biotek & Materialer
Teknik & Teknologi
Data & analyse
Forskning & Udvikling
IT - Hardware
IT - Netværk & Telekomm.
IT - Software



NNIT A/S - hurtigt overblik


NNIT A/S
NNIT A/S
IT advisory, development and operations with a strong focus on life sciences, finance, the public sector and large enterprises with equally high demands on quality and security.

Placering
Østmarken 3A
2860 Søborg
Logo: NNIT A/S
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