Manufacturing Equipment Qualification

Overview

On Site
$DOE
Full Time
Accepts corp to corp applications
Contract - W2
Contract - Independent
Contract - 3 day((s))

Skills

Verification And Validation
Accountability
Software Development Methodology
Risk Management
Corrective And Preventive Action
Test Management
GAMP
Radio
Forms
Real-time
Regulatory Compliance
Computerized System Validation
Software Testing
System Implementation
Manufacturing
Stakeholder Management
Communication
Pharmaceutics
Life Sciences
MES
QMS
LIMS
Business Analytics
Testing
HP ALM

Job Details

Job Title: Manufacturing Equipment Qualification

Location: Indianapolis, IN (Onsite)

Duration: 12+ Months

Job Description:

Mandatory Skills:

Well versed with Manufacturing, Quality and engineering system and their validations.

OT System Qualification (Radio ligand Therapy or critical dosage forms will be a plus), PAS/DCS Integrated with Manufacturing Equipment qualification.

  • Candidate will provide an application validation expertise practically on different scenarios as applicable case to case i.e., standalone/enterprise etc.
  • Candidate will be accountable for authoring Validation Plan, and Validation Summary Reports and have fair understanding on other SDLC documents.
  • Candidate must have fair conceptual understanding on below key areas.
  • IT QMS
  • Validation/Qualification
  • Risk management.
  • Handling of defects/Deviations
  • Investigations
  • CAPA Handling
  • Test Management & Compliance
  • Candidate must have understating on latest regulations i.e., 21CFR Part 11, EU annex 11, and Guidelines e.g., GAMP5 guide.
  • OT System Qualification (Radio ligand Therapy or critical dosage forms will be a plus)
  • PAS/DCS Qualification
  • ISA95 High level of understanding
  • OT Security will be a plus.
  • Standalone Systems Qualifications
  • PAS/DCS Integrated with Manufacturing Equipment qualification.

Essentials / Desirable

  • 10 to 12 years of Professional experience and strong knowledge with real time experience in IT Quality & Compliance, Computer System Validation / Software Testing / System Implementation in the Life Sciences industry.
  • Well versed with Manufacturing, Quality and engineering system and their validations.
  • Stakeholder management and good executor with required communication.
  • Knowledge of Pharmaceutical / Life Sciences as domain.
  • Experience to MES, QMS (Track wise), Lab solutions i.e., LIMS, Empower CDS, Chromeleon, Business Analytics, Middle wares etc.

Nice to Have Skills

  • Hands-on experience on testing tools like HP ALM, Kneat and SNOW
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