QA Specialist/QP
We are seeking a highly skilled QA Specialist/QP to join our team at scientificjobs.
Description
Our client is a leading manufacturer and distributor of X-ray and MRI Contrast Media. As part of the Pharmaceutical Diagnostics (PDx) business, we support the PDx vision of delivering the right dose to the right patient at the right time.
Responsibilities
* Coordinate certification of finished product batches to market as required under EU directive 2001/83/EC.
* Evaluate batch and manufacture for compliance with GDP, GMP, Regulatory Licenses, and Marketing Authorization.
* Maintain oversight of deviations, CAPA & Change Controls, and notify health authorities and mitigate issues as necessary.
* Continuously improve manufacturing and quality systems by identifying and implementing efficiencies from a systematic and compliance perspective.
* C Coordinate support for operations in general troubleshooting and problem-solving, providing technical direction and guidance to support overall business needs.
* Maintain up-to-date knowledge of pharmaceutical legislation and industry best practices.
Qualifications and Experience
* 3rd level qualification in Science or Engineering discipline or equivalent knowledge or experience.
* SIGNIFICANT experience within a GMP/QA environment in a pharmaceutical company or similar regulated environment.
* Eligible to act as Qualified Person in line with local and EU directives.
Desired Skills
* Ability to create and maintain effective interpersonal relationships with all levels of personnel within cross-functional departments.
* Excellent communication, negotiation, and risk-based decision-making skills promoting openness, dialogue, and collaboration.
* Results-oriented with strong ability to effectively troubleshoot and problem-solve issues.
* Promote a continuous improvement culture.
Eligibility Requirements
* Good level of English and valid work permit.
* Level 8 degree enabling QP eligibility (MSc Pharm, for example).