Overview
On Site
Full Time
Skills
Pharmacy
COTS
Quality Control
Research and Development
Manufacturing Operations
Pharmaceutics
Medical Devices
GxP
Data Integrity
LIMS
Analytical Skill
Instrumentation
Quality Management
Process Engineering
Quality Assurance
Workflow
Computerized System Validation
Computer Networking
Attention To Detail
Communication
GAMP
Software Development Methodology
Job Details
Roles & Responsibilities:
- Pharmacy Verification Support engineer for a minimum of 4 years.
- Working knowledge of software or system validation in regulated industry like Medical Device or Pharma.
- Strong knowledge and experience of computerized system development life cycle (SDLC) approaches and validations strategies is required.
- Experience with COTS/Custom made Analytical Instrument and experience working in QC Laboratories, R&D, manufacturing/operations is required.
- Software Quality Engineer (SQE)/ Computer System Validation (CSV) experience in Pharma/Medical Device is required.
- Good knowledge of the areas of GxP is required including knowledge of CSV and data integrity regulations including but not limited to 21 CFR Part 11.
- Experience in LIMS/CDS/ Analytical Instrumentation Validation is preferred and not mandatory.
- Familiar or Experience in Quality Systems process development, support, integration, or enhancement is preferred.
- Software Quality Engineer certification (CSQE) or Certified Quality Engineer certification (CQE) is preferred not mandatory.
- Strong knowledge and experience of computerized system development life cycle approaches and validations strategies is required.
- Familiarity with bioanalytical work and workflows, instrument software, and computer systems validation in the bioanalytical space is preferred.
- Excellent communication, social skills, networking skills, a high level of organizational ability, and attention to detail is required.
- Good interpersonal skills and Communication with the system administrator, system owner, and lab manager to plan, coordinate, implement and validation.
- Working knowledge of GAMP5 and SDLC is preferred A minimum of 4 years of experience in a regulated environment is required.
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