Full-Time
CAI
1-10 employees
Consulting for operational readiness in healthcare
No salary listed
Junior, Mid
Milan, Metropolitan City of Milan, Italy
Candidates must be available for travel throughout Italy and some European travel may be required.
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- Provides knowledge and experience in Quality Systems and/or Operational Quality such as the following i.e., Deviation/ Change Control /Laboratory Investigations / Environmental Monitoring etc.
- Strong cGMP and regulatory requirement understanding.
- Experience in Trackwise.
- Excellent oral and written English are required.
- Suitable candidates must be available for travel throughout Italy and some European travel may be required.
- Performs Batch Disposition preparation, Batch record review, Certification process oversight.
- Support all quality and compliance requirements for and leading to commercial manufacturing.
- Uses knowledge to improve Quality Systems and/or Operational Quality with clients; solve complex problems and provide guidance and support for continuous improvement.
- Understands and applies regulatory / compliance requirements to the role ensuring alignment and recommendation with current or upcoming regulatory and compliance changes.
- Interprets client’s needs, assesses requirements, and identifies solutions to non-standard requests.
- Ensure the highest Quality, Compliance and Safety standards.
- Works collaboratively to facilitate client and ensure alignment and best practices adopted for Quality System related topics and/or Operational Quality.
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