New opportunity available to join our client - global biopharmaceutical company in Dublin 15 as a Qualified Person on Manufacturing/Importation Authorisation for an initial 12 months contract.
Main responsibilities
• Qualified Person certification and batch release of clinical supplies
• Acts as a Responsible Person on a WDA for Pre-Approval Access
• Support for Health Authority GMP/GDP inspections and audits across the supply chain
• Advise stakeholders on quality issue management and process enhancement/compliance - ensuring consistent quality standards and fostering strong working relationships
• Incorporate global regulatory trends and changes into Supply Chain Quality
• Site master file maintenance
• Manufacturers Authorisation update and maintenance
• Ensure rapid communication of quality issues or significant deviations, to business partners and senior management
• Review and approve procedural documents
• Participate in multidisciplinary or cross-functional work/project teams; serve as part of strategic team(s) within the group/discipline
• Provide guidance and expectations to the business to enable execution of external and internal regulations on a global and cross functional level
• May influence the external environment through interactions with regulators, trade associations, or professional societies
• Proactively identify risk areas
• Provide input in the global audit plans based on identified signals/trends/risks/gaps
• Undergo continuous professional development including self-study, site visits, internal and external training courses and audits
• Support OPEX programs and champion continuous quality improvement initiatives
Qualifications
• A degree in science, engineering or related discipline is essential along with 10 years’ experience in a role within the biopharmaceutical/pharmaceutical industry
• Must be eligible to act as Qualified Person on the Manufacturing/Importation Authorisation
• Previous experience as a Responsible Person on a WDA is preferred
• Demonstrated strong knowledge of ICH/GMP, data integrity, regulatory guidelines/directives, clinical supply chain processes and principles of Quality Assurance
• Proven track record of building/ maintaining high-performance teams/organizations and influencing/ motivating global teams to achieve results—delivering on business and program goals
• Proven leadership / influence management skills with ability to foster partnerships in the matrix organization across functional/ geographic/ cultural/partner boundaries
• Proven clear communication supporting delivery for the business
• Fosters a culture in which people continually work to improve services, and work processes
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