Lab System Validation

Rahway, NJ

$87K - $118K (Glassdoor est.)

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Roles & Responsibilities:

Experience/ exposure to Computerized System Validation (CSV), US FDA 21 CFR Part 11, EU Annex 11 and GAMP 5.
Experience of CSV Validation in any one of the Lab systems is must.
Should worked in pharmaceutical domain and its related knowledge is must
Good communication and technical writing skills are a must
Developing validation documentation for pharmaceutical equipment, facilities and computerized systems used in GLP, GMP and GCP environments.
Project Deliverables will encompass validation plans, specifications, test protocols and standard operation procedures and systems may include Process Automation, Laboratory Automation, Enterprise IT Applications and Network Infrastructure.
CSV, GAMP 5 CPFR Part 11, Validation, Worked in V model, SOP & SDLC Lifecycle. Adaptation of CSA and Module Validation is preferred.
To provide a planned approach for the implementation of the CSV deliverables, migration due diligence, GXP and Non GXP areas
Provide guidance and leadership regarding Regulatory Compliance and Quality Management requirement.
Prepare and execute URS, MVP, VP, RTM, TP, IQ, OQ, PQ, VSR, Traceability Matrix etc.
Exposure to Regulatory Audits and Remediation activities
Ensure the CSV artefacts are in line and meets regulatory requirements
Preferred Experience in Agile Development
Knowledge on working in Jira / Service Now
Adaptation to AI is preferred.
Testing (in addition to above)
Experience in testing and knowledge in any one of the QC/R&D Lab systems is must.
Prepare and execute TP, IQ, OQ, PQ, TSR, Traceability Matrix etc is must.
Knowledge on working in Jira, Client ALM or any automation testing tools.

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Base pay range

The minimum salary is $87K and the max salary is $118K.

$87K – $118K/yr (Glassdoor est.)

$101K

/yr Median

Rahway, NJ

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Working here doesn’t have to be a secret

3.1

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CEO: Katalyst HLS
3 Ratings

Katalyst Healthcares & Life Sciences

3.1

Lab System Validation

Rahway, NJ

$87K - $118K (Glassdoor est.)

Katalyst Healthcares & Life Sciences

3.1

Lab System Validation

Rahway, NJ

$87K - $118K (Glassdoor est.)

Is your resume a good match?

Use AI to find out how well the skills on your resume fit this job description.

Roles & Responsibilities:

Experience/ exposure to Computerized System Validation (CSV), US FDA 21 CFR Part 11, EU Annex 11 and GAMP 5.
Experience of CSV Validation in any one of the Lab systems is must.
Should worked in pharmaceutical domain and its related knowledge is must
Good communication and technical writing skills are a must
Developing validation documentation for pharmaceutical equipment, facilities and computerized systems used in GLP, GMP and GCP environments.
Project Deliverables will encompass validation plans, specifications, test protocols and standard operation procedures and systems may include Process Automation, Laboratory Automation, Enterprise IT Applications and Network Infrastructure.
CSV, GAMP 5 CPFR Part 11, Validation, Worked in V model, SOP & SDLC Lifecycle. Adaptation of CSA and Module Validation is preferred.
To provide a planned approach for the implementation of the CSV deliverables, migration due diligence, GXP and Non GXP areas
Provide guidance and leadership regarding Regulatory Compliance and Quality Management requirement.
Prepare and execute URS, MVP, VP, RTM, TP, IQ, OQ, PQ, VSR, Traceability Matrix etc.
Exposure to Regulatory Audits and Remediation activities
Ensure the CSV artefacts are in line and meets regulatory requirements
Preferred Experience in Agile Development
Knowledge on working in Jira / Service Now
Adaptation to AI is preferred.
Testing (in addition to above)
Experience in testing and knowledge in any one of the QC/R&D Lab systems is must.
Prepare and execute TP, IQ, OQ, PQ, TSR, Traceability Matrix etc is must.
Knowledge on working in Jira, Client ALM or any automation testing tools.

See company reviews

Base pay range

The minimum salary is $87K and the max salary is $118K.

$87K – $118K/yr (Glassdoor est.)

$101K

/yr Median

Rahway, NJ

Working here doesn’t have to be a secret

3.1

Recommend to a friend
Approve of CEO
CEO: Katalyst HLS
3 Ratings

3 TSR/CSA jobs in United States

Base pay range

Working here doesn’t have to be a secret

Base pay range

Working here doesn’t have to be a secret