Quality & Regulatory Specialist

at  Cencora

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!
What you will be doing

POSITION SUMMARY:

We’re hiring the Quality & Regulatory Specialist to join our dynamic Quality Team in Cork, Ireland.
The primary responsibility will be to support the maintenance and improvement of the Quality Management System and quality assurance activities, ensure compliance with cGDPs, in addition with supporting regulatory affairs.
The Quality & Regulatory Specialist should have sufficient knowledge of GDP to conduct the role. This should include a knowledge of the EU GDP Guidelines, the Medicinal Products (Control of Wholesale Distribution) Regulations 2007 (S.I. No. 539 of 2007), as amended, and any supplementary guidance issued by the HPRA.

EXPERIENCE AND EDUCATIONAL REQUIREMENTS:

• BS in a scientific discipline preferred.
• Minimum of three (3) to five (5) years in a cGMP/GDP facility in a Quality Assurance/Regulatory role.
• The preferred candidate must have experience with EU GDP Guidelines.
• Proficient in Microsoft Office (Excel, Word, PowerPoint & Outlook)

MINIMUM SKILLS, KNOWLEDGE, AND ABILITY REQUIREMENTS:

• Strong analytical skills and critical thinking ability
• Ability to work under pressure and deliver results under several deadlines.
• Strategic mindset and agile delivery
• Self-sufficient and innovative
• Good teamwork and ability to develop interpersonal relationships.
• Strong and structured communication techniques
• Ability to read and understand legal documents and contracts.
• Good problem-solving skills to evaluate quality problems and apply knowledge to identify appropriate solutions.
• Be willing and available for international travel as needed to meet business needs.
  What Cencora offers
  All team members globally are provided with basic life insurance, personal accident insurance, business travel accident insurance, and EAP resources at no cost. Additional country-specific benefits such as healthcare, sick leave, death and disability, retirement, as well as perks and allowances may be provided. Details of programs vary by location.
  Schedule
  Full time
  Affiliated Companies
  Affiliated Companies: Cencora Global Procurement Limited
  Equal Employment Opportunity
  Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.
  The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.
  Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email
  hrsc@amerisourcebergen.com
  . We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returne

• Maintain the quality system and ensure that it demonstrates adherence to Good Distribution Practices (GDP’s) and Cencora Policies and procedures. •
• Track supplier approvals and ensure that due diligence (Bona fides) is conducted at regular intervals.
• Ensure that supplier’s & customers are qualified as per internal procedures.
• Support and monitor the implementation of existing & new quality related agreements and fulfilment of the organization’s technical obligations focusing on maintaining compliance.
• Address and resolve quality events to solve problems and improve systems by working with internal and external parties, develop and implement corrective and preventative actions and document quality event resolution.
• Liaise with the Quality Manager on regular Quality review meetings, identifying opportunities for improvement.
• Manage the Corrective & Preventive Action process and ensure effective CAPA’s are implemented following identification of a root cause and approval from the Quality Manager/RP.
• Support external audits with regulatory agencies and support close out any findings in a timely manner.
• Ensure that all good distribution records are maintained, and records are accurate.
• Liaise with regulatory authorities and/or other Cencora teams as required to ensure appropriate registrations & licenses are up to date & in compliance.
• Supports on change controls, self-inspections, deviations, recalls and customer complaints and other Quality Assurance activities when required.
• Manage & develop the key performance indicators (KPIs) to monitor areas of Quality and identify areas for improvement.
• Lead relevant parts the electronic Document Management Application and identify areas for development to improve productivity.
• Ensure personnel induction training and ongoing GDP training is maintained.
• Keep up to date with all relevant regulatory updates and update the quality management system to ensure compliance.
  What your background should look like