Overview
On Site
Full Time
Skills
Documentation
Standard Operating Procedure
Quality Assurance
Regulatory Compliance
Training
Auditing
Life Sciences
Conflict Resolution
Problem Solving
Attention To Detail
Effective Communication
Teamwork
Collaboration
Pharmaceutics
Biotechnology
Job Details
Responsibilities:
- Prepare commissioning, qualification, and validation documents for equipment, utilities, and systems.
- Verify that systems and equipment operate according to design specifications and regulatory requirements.
- Prepare and maintain comprehensive validation documentation, including test protocols, reports, and standard operating procedures.
- Work closely with engineering, quality assurance, and production teams to resolve issues related to CQV.
- Implement corrective actions and improvements to maintain compliance with regulatory standards.
- Stay updated on industry regulations and standards related to CQV and ensure that all activities meet these requirements.
- Conduct training sessions on CQV procedures and best practices for employees.
- Participate in internal and external audits related to CQV activities.
- Bachelor's degree in engineering, life sciences, or a related field.
- Strong understanding of CQV protocols and regulatory requirements.
- Excellent problem-solving skills and attention to detail.
- Effective communication and teamwork abilities.
- Relevant experience in the pharmaceutical or biotechnology industry is preferred.
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