GMP Compliance Expert
4 days ago
PSC Biotech Corporation is seeking an experienced GMP Compliance Expert to join our Engineering Department. In this role, you will be responsible for ensuring that our company's products meet the highest quality and safety standards.
About Us
PSC Biotech Corporation is a leading Biotech Consultancy firm with operations globally. We provide cloud-based software solutions for Quality Management and Regulatory Inspections to our clients in the pharmaceutical and biotechnology industries.
Responsibilities
- Support the Engineering Department in maintaining a GMP-compliant environment
- Lead investigations into deviations, out-of-tolerance conditions, and unexpected results
- Analyze data to identify trends and areas for improvement
- Develop and maintain necessary documentation, including SOPs, SWIs, training documents, JSAs, PMs, and change controls
- Collaborate with Engineering colleagues and other departments to ensure compliance with global policies, procedures, and regulatory requirements
Requirements
- Degree in a related field (diploma or higher preferred)
- Minimum 4-5 years of experience in a manufacturing setting, preferably in a GMP environment
- Strong understanding of regulatory/code requirements, including Irish, European, and International Codes, Standards, and Practices
- Effective communication and interpersonal skills, with ability to interface effectively with all levels of colleagues and external customers
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