Deviation Author / Investigator - GxP Environment

NNIT A/S

Fuldtidsjob
Storkøbenhavn

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.

Deviation Author / Investigator

Specific Skills/Qualification Requirements

Excellent writing skills

Broad knowledge of pharmaceutical quality- with expertise in computer systems compliance

Experienced in authoring deviations and CAPAs

Knows how to apply Root Cause Analysis tools such as Ishikawa and 5 Whys

Job Description

Independently conduct and document investigations related to deviations from GxP requirements.

Facilitate cross-functional meetings with internal and external parties.

Apply Root Cause Analysis tools to identify root causes and propose effective corrective and preventive actions.

Authors corrective actions that are effective in addressing root causes.

Ability to get the job done in a dynamic, time-limited, KPI-driven environment

Keeps tracking tools/databases current

Project manage records and stakeholders to ensure on-time completion

Sufficient political awareness & industry knowledge to know when to escalate issues

Participate in the development of training programs regarding all aspects of producing quality products, as required.

Assist in compliance audits as required.


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Fuldtidsjob
Storkøbenhavn
IT
Kemi, Biotek & Materialer
Naturvidenskab
Teknik & Teknologi
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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https://jobbank.dk/job/1397854/