Full-Time
CAI
1-10 employees
Consulting for operational readiness in healthcare
No salary listed
Senior
Italy
The candidate must be available for travel throughout Italy and some European travel may be required.
- CSV
- IT
- GMP based knowledge
- Excellent oral and written communication skills in English/Fluent in English
- Ability to balance the long-term ('big picture') and short-term implications of individual decisions
- Prepares/reviews validation documentation related to projects/change controls.
- Manages change controls and other compliance related tasks e.g. non-conformances.
- Participates in the review of current and future CSV procedures and policies.
- Analyses the results of testing and determines the acceptability of results against predetermined criteria.
- Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
- Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation, and maintenance of the procedures, actions, and documentation necessary to ensure compliance within the operation.
- Coordinates with other departments or outside contractors/vendors to complete validation tasks.
- Participates in regulatory audits and communicates company’s computer validation policies.
- Assesses company’s computer systems and identifies any potential Part 11 or Annex 11 gaps.
- Manages projects and prepares status reports using Microsoft project and other communication tools.
- Demonstrated ability with information technology delivery for regulated businesses highly desirable, specifically in supporting IT delivery or transition in manufacturing or integrations.
- Leadership experience in a matrixed environment preferred.
CAI Technical Consulting Malaysia SDN, under the brand cagents.com, offers consulting services focused on operational readiness for clients in the pharmaceutical, biotechnology, and healthcare sectors. They conduct operational readiness assessments to evaluate a company's preparedness and tailor their services accordingly, which include project planning and asset management. CAI stands out from competitors by emphasizing professional development and industry collaboration, ensuring their team stays updated on industry trends. Their goal is to help clients achieve operational excellence and readiness for full-scale production.
Company Size
1-10
Company Stage
Pre-seed
Total Funding
$3.4M
Headquarters
Overland Park, Kansas
Founded
1996
Simplify's Take
What believers are saying
- Demand for digital transformation in life sciences boosts CAI's automation consulting services.
- Personalized medicine trends create opportunities for flexible manufacturing process consulting.
- Data centers' focus on energy efficiency aligns with CAI's energy management expertise.
What critics are saying
- Competition from specialized firms in digital transformation may erode CAI's market share.
- In-house consulting teams in corporations could reduce demand for CAI's services.
- Remote work models decrease demand for traditional on-site consulting, impacting CAI's operations.
What makes CAI unique
- CAI offers comprehensive consulting services across multiple industries, including life sciences.
- Their expertise in energy management aligns with the sustainability focus of data centers.
- CAI's risk management services cater to the growing cybersecurity needs in process manufacturing.
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Benefits
100% Employee Owned
24 Days PTO/5 Sick days per year + Additional Holidays depending on Country
Medical / Dental / Vision (In accordance with each countries’ applicable regulations)
Professional Development (Approximately $5,000 paid career-related, continuing education)
ESOP/401k – 15% Company Contribution
Company Paid Long-Term Disability
Company Paid Life Insurance
Company Paid Parental Leave (In accordance with each countries’ applicable regulations)
Other Benefits Depending on Country