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Quality Assurance Specialist

Contract Type: Permanent
Location: Dublin
Contact Name: Gavin Kennedy
Contact Email: gavin@rftgroup.ie

Job Description

Quality Assurance Specialist
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
Key Duties:
  • 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
Personal Attributes Needed:
  • 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
QUALIFICATIONS:
  • 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
EDUCATION:
  • BS in scientific discipline or equivalent
Cv to gavin@rftgroup.ie 01 2302400 www.rftgroup.ie