2 years experience in pharmaceutical or medical device
Drafting cqv and csv deliverables like urs and rtm
The role involves delivering consulting projects to support the implementation of laboratory enterprise systems for Life Sciences clients
Job Summary
The role involves delivering consulting projects to support the implementation of laboratory enterprise systems for Life Sciences clients.
Candidates will be responsible for drafting critical regulatory documents such as URS, risk assessments, and IOPQ protocols.
ORKA offers a professional environment with extensive learning opportunities, mentoring, and access to training materials from experienced industry leaders.
Matching Summary
Match Score: 75
The role involves delivering consulting projects to support the implementation of laboratory enterprise systems for Life Sciences clients.
Skills & Requirements
Must-have
Bachelor's degree in Life Sciences or Engineering
2 years experience in pharmaceutical or medical device
Drafting CQV and CSV deliverables like URS and RTM
Nice-to-have
Experience configuring LIMS, LES, ELN, or CDS systems
Knowledge of Windows Upgrade for laboratory equipment
Understanding of change, incident, and problem management
Key Requirements
Bachelor's degree in Life Sciences, Engineering, or related field
Minimum 2 years of work experience in pharmaceutical or medical device sectors
Understanding of 21 CFR Part 11 and Annex 11 regulations