Job Description
Our client requires a highly motivated and experienced individual for the position of Quality Specialist, Development & External QA (Audit Management). This individual will be part of the Development & External QA Operations group and will be based in Ireland
RESPONSIBILITIES:
- Develop and Manage the Clinical Phase and Commercial Contractor Quality Management (CQM) Program for solid dosage, sterile and biologic dosage forms including preparation for external regulatory inspections.
- Develop and Manage the internal auditing program for External Operations
- Manage additional auditing personnel and perform vendor audits, and other qualification activities for Contracted Manufacturing, Packaging/Labeling, and Laboratory Organizations, Active Pharmaceutical Ingredient (API) vendors, key excipient vendors and early phase raw material vendors
- Management and maintenance of the contractor and clinical phase suppliers GMP Approved Supplier List (ASL) and Audit Schedule
- Support of Quality/Technical Agreements, External Service Agreements
- Auditor training with a focus in data integrity auditing; qualifying auditors and SMEs for external auditing
- Troubleshoots issues, develops and implements effective risk mitigation strategies as required
- Support and collaborate with the External Operations Team as well as site development teams
- Expert knowledge on regulatory requirements and industry expectations for Vendor / supplier Quality Management
- Working knowledge of US and European Drug Product GMP requirements and associated guidelines including working knowledge of ICH Q7 API GMP Guide
- Experience with Quality System Regulation (QSR), GCP, and/or GLP is considered a plus
- Experience in administration and development of quality systems
- Experience in Pharmaceutical Quality Assurance, including the ability to identify and resolve compliance issues
- Experience in product development and expectations for early phase clinical trials
- Strong decision maker, applies job related skills and understanding of policies and standards in completing tasks
- Strong focus on continuous improvement, customer service and collaboration
- Strong written and oral communication skills
- Ability to be influential across different levels of the organization
- Demonstrated leadership skills are critical to this role
- Team Player committed to quality
- Motivated self-starter committed to detail and results
- Well organized, efficient worker with good communication skills
- Innovative thinker and problem solver with flexibility to embrace change and manage multiple duties and tasks
- Ability to work in a fast-paced environment with multiple issues open simultaneously
- Customer service mindset, identifies opportunities to improve and contributes to problem solving
- Ability to travel up to 40% of the time
- 10-15 years of experience in a Quality Assurance role in the pharmaceutical industry; preferably with parenteral and oral dosage forms
- Certified Quality Auditor is considered a plus
- BS in scientific discipline or equivalent