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Perform moderately complex activities pertaining to assuring compliance with applicable regulatory requirements. Conduct internal audits; assist with customer audits, and track audit corrective actions.
Job Responsibility:
Assists with internal audit program by conducting audits, writing audit reports, evaluating responses to audit observations, and verifying closure of corrective actions
Assists with vendor quality program by conducting paper audits and tracking vendor quality issues and changes
Assists with customer audit program by retrieving and preparing documentation, communicating and coordinating with internal SMEs, and tracking completion of corrective actions
Assists with regulatory inspection process by retrieving requested documentation and communicating with SMEs
Regular and reliable attendance on a full time basis
Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices
Embodies PCI Pharma’s cultural values and aligns daily actions with department goals and company culture
Requirements:
Bachelor’s degree in Life Sciences discipline or equivalent preferred
Minimum of two to four (2-4) years of experience in a GMP environment
Basic understanding of regulatory requirements related to aseptic drug product manufacturing and testing
Good understanding of internal requirements related to quality management systems, risk management, and supplier qualification
Developing communication and team collaboration skills
Detail-oriented with strong organizational skills
Proficient with Microsoft Office applications
What we offer:
Annual performance bonus
Paid time off
Health insurance coverage (including dental and vision)