Quality Records Team Lead

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 have 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 Team Lead

We are currently seeking an experienced and dedicated Quality Assurance Team Lead to work on location in San Francisco to support one of our top clients.

Description:

This person will be responsible for

Leading a medium-sized team in support of the creation and maintenance of Quality Management System records (e.g. training, coaching, mentoring and hiring/developing people)

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.

Formally track Deviations, CAPA’s, and change management records, to ensure KPIs are met in accordance with agreed upon SLAs.

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

Requirements

2 – 4 years experience leading teams

5 – 8 years’ experience validating GxP systems within the pharmaceutical, biotech, or medical device fields

Excellent communication skills (verbal, written); able to communicate clearly at all levels of the organization, including senior management

Working experience creating or reviewing/approving Deviation, CAPA, and Change Management Quality Management System (QMS) records

Working experience creating or reviewing/approving 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


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Fuldtidsjob
Udlandet (øvrige)
IT
Kemi, Biotek & Materialer
Naturvidenskab
Teknik & Teknologi
Data & analyse
IT - Hardware
IT - Netværk & Telekomm.
IT - Software
Ledelse & Planlægning
Produktion



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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