Validation Specialist
3 weeks ago
We are seeking an experienced Validation Specialist - Computerized Systems to join our team at CPMNA. The successful candidate will be responsible for ensuring the compliance of our computerized systems with regulatory requirements, such as 21 CFR Part-11 and Annex-11 Data Integrity.
Key Responsibilities:
- Develop and implement validation protocols for computerized systems, including DCS, SCADA, and BMS systems.
- Conduct reviews and approval of SDLC deliverables, including software development lifecycle documentation.
- Collaborate with cross-functional teams to ensure compliance with regulatory requirements and industry standards.
- Provide training and support to colleagues on regulatory compliance matters.
- Participate in regulatory audits and inspections as a subject matter expert.
Requirements:
- Master's degree in Computer Science, Life Sciences, Engineering, or similar discipline with three (3) years of experience in computer system validation activities in pharmaceutical, biotechnology, or related industry.
- Bachelor's degree in Computer Science, Life Sciences, Engineering, or similar discipline with five (5) years of experience in computer system validation activities in pharmaceutical, biotechnology, or related industry.
- Associate's degree in Computer Science, Life Sciences, Engineering, or similar discipline with seven (7) years of experience in computer system validation activities in pharmaceutical, biotechnology, or related industry.
Salary: $90,000 - $120,000 per annum, depending on qualifications and experience.
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