Job Description
Are you a highly motivated and experienced individual for the position of Development & External QA (Audit Management). You will will be part of the Development & External QA Operations group and will be based in Dublin
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
QUALIFICATIONS:
BS in scientific discipline or equivalent
8 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
Ability to travel up to 40% of the time
For further information on this QA Specialist position please contact Laurentina Kennedy at The RFT Group on 01 2302400 / Laurentina@rftgroup.ie. Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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