Quality Assurance Specialist

4 weeks ago


Dublin, Dublin City, Ireland Xcenda, LLC Full time

Quality Assurance Specialist page is loaded

Quality Assurance Specialist Apply locations Cork, Ireland time type Full time posted on Posted 2 Days Ago job requisition id R247699

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

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POSITION SUMMARY:

We're hiring the Quality Assurance 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.

PRIMARY DUTIES AND RESPONSIBILITIES:

  • 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

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 or email . We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

About Us

Cencora is a leading global pharmaceutical solutions company that is committed to improving the lives of people and animals everywhere. We connect manufacturers, providers, and patients to ensure that anyone can get the therapies they need, where and when they need them.

We're a purpose-driven organization, where all of our team members around the world are united in our responsibility to create healthier futures. We work together every day to help our partners bring their innovations to patients worldwide, creating unparalleled access and impact at the center of health.

Job Scams

Recruitment scams are on the rise and the intent is to target individuals looking for employment opportunities. To protect yourself, we urge you to be vigilant and follow these guidelines.

1.) Research the Company: Thoroughly research any company before applying or sharing personal information, check their website, read reviews, and verify their legitimacy.

2.) Be Wary of Unrealistic Promises: Exercise caution If a job posting offers high salaries and minimal qualifications. Legitimate jobs will have realistic expectations and provide detailed job requirements. Jobs at Cencora can be found on

3.) Guard Your Personal Information: Only share sensitive information after vetting the employer's credibility. Avoid sharing your Social Security number, bank account details, or identification documents during the application process. Cencora does not request this information as part of the employment application.

4.) Avoid Upfront Payments: Legitimate employers do not require payment during the hiring process. Be suspicious if you are asked to pay for training materials, processing fees, or background checks before securing a job offer. Cencora will never ask you for payment information during the hiring or onboarding process.

5.) Verify Communication Channels: Scammers often use free email services or chat platforms without providing an official company contact information. Cencora recruiters will have an email address ending in , @alliance-, @alliance-, alliance- or alliance-

Remember to stay vigilant and informed about common scam tactics to reduce the risk of falling victim to fraudulent employment schemes.

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