QA Reviewer / Consultant

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 Records Reviewer / Consultant

We are currently seeking an experienced and dedicated Quality Assurance Records Reviewer / Consultant to work on location in San Francisco to support one of our top clients

Description:

This person will be responsible for

Ensuring that the documentation supporting change management records and CAPAs adhere to 21 CFR Part 11, Annex 11, GMP (21 CFR Part 211), GAMP 5, GDP, and applicable SOPs.

Preparing change management plans, including description and justification of the change, impact to system (e.g. risk, validation, documentation, functionality, security, data integrity), and change implementation plan.

Formally track CAPA’s and change management records, to ensure deadlines for implementation and closure are met.

Review supporting documentation for change management records and CAPAs to ensure completion of all required activities including, but not limited to, system reports, qualification protocols (IQ, OQ, PQ), and other supporting evidence.

Leading investigation of deviations, including conducting and participating in investigation meetings, gather information about the deviation (e.g. interview personnel, inspect audit trail and documents), determination of root cause, and proposing CAPA actions to address the root cause of the deviation.

Preparing CAPA Plans that includes purpose, scope, risk mitigation strategies, and clearly identify CAPA actions along with specific deliverables required to complete the CAPA actions.

Requirements:

2-5 years’ experience reviewing and validating GxP systems and documentation within the pharmaceutical, biotech, or medical device fields

Working experience with CAPAs and Effectiveness Checks, as well as other Quality Management System (QMS) records (e.g. Deviations, Change Management)

Able to create computer system validation (CSV) deliverables (Validation Plans, User/Functional Requirements, Design Specs, Qualification Protocols (IQ / OQ / PQ), Summary Reports, Trace Matrices, SOPs)

Familiar with one or more of the following types of systems: QMS (e.g. TrackWise), EDMS (e.g. Documentum, Veeva Vault), Learning Management System (e.g. ComplianceWire), ERP System (e.g. Oracle EBS), Virtualization (e.g. VMware), computer infrastructure (e.g. switches, Windows/Linux servers)

Able to understand current work processes, as described in Work Instructions, SOPs and policies

Able to quickly develop working knowledge of complex computer systems leveraging SMEs, vendor documentation, and SOPs

Able to work both as part of a team and independently

Excellent communication skills (verbal, written)

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
Naturvidenskab
Teknik & Teknologi
Data & analyse
IT - Hardware
IT - Netværk & Telekomm.
IT - Software
Produktion
Rådgivning & Support



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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