Senior Pharmaceutical Commissioning Qualification Validation Specialist
4 weeks ago
CAI is seeking a Senior Pharmaceutical Commissioning Qualification Validation Specialist to join our team in Australia. The successful candidate will be responsible for developing documentation to support Commissioning, Qualification, and Validation activities in the pharmaceutical industry. The role will involve working with clients to develop protocols, executing field verifications, and developing summary reports.
About CAI
CAI is a 100% employee-owned company established in 1996, with a strong presence in Australia. We provide commissioning, qualification, validation, start-up, project management, and consulting services related to operational readiness for FDA-regulated industries. Our team of experts has extensive experience in the pharmaceutical, medical device, and biotechnology sectors.
Key Responsibilities
- Develop documentation for Commissioning, Qualification, and Validation activities in the pharmaceutical industry
- Collaborate with clients to develop protocols and execute field verifications
- Develop summary reports to document Commissioning, Qualification, and Validation activities
- Work with clients to plan and coordinate Commissioning, Qualification, and Validation activities
Requirements
- Bachelor's or Master's degree in a relevant science or engineering field
- 5-12 years of experience in Commissioning and/or Qualification activities in an FDA-regulated industry
- Excellent technical problem-solving and troubleshooting skills
- Strong attention to detail and ability to multi-task
- Ability to work independently and as part of a team
- Familiarity with life science manufacturing processes and equipment
- Proficient in Microsoft Word and Excel
- Strong communication and interpersonal skills
What We Offer
- Competitive salary and benefits package
- Opportunities for professional development and growth
- Collaborative and dynamic work environment
- Chance to work on cutting-edge projects in the pharmaceutical industry
- Employee ownership and benefits
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