Quality Compliance and Regulatory Affairs Manager (Budapest)

Quality Compliance and Regulatory Affairs Manager (Budapest)
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Quality Compliance and Regulatory Affairs Manager



ABOUT THE JOB

  • ensuring that a quality system is implemented, maintained and aligned with the corporate guidelines;
  • focusing on the management of authorized activities and the accuracy and quality of records;
  • ensuring that initial and continuous training programs are implemented and maintained;
  • ensuring that all products are subjected to a proper reception inspection process;
  • approving product to be distributed to the market (commercial release in relation with warehouse activities);
  • coordinating and promptly performing any recall operations for products on the market following the related escalation and market event management processes;
  • Primary/preferred reference contact with the authority regarding quality and market event;
  • ensuring that relevant customer complaints are dealt with effectively;
  • ensuring that suppliers and customers are approved;
  • approving any subcontracted activities which may impact on good distribution practice (qualification through audit and QA agreement);
  • ensuring that self-inspections are performed at appropriate regular intervals following a prearranged program and ensuring that the necessary CAPA are put in place;
  • keeping appropriate records of any delegated tasks.
  • deciding on the final disposition of returned, rejected, recalled or falsified veterinary medicinal products.
  • approving any returns to saleable stock.
  • ensuring that any additional requirements imposed on certain veterinary medicinal products by national law are adhered to.
  • documenting deviations and deciding on CAPA to correct deviations and avoiding their reoccurrence and monitoring of the effectiveness of those CAPA.
  • ensure that post-marketing studies are duly approved by the relevant instances prior to being conducted.
     

ADDITIONAL HIGHLIGHTS

  • Knowing and observing the Company rules about Pharmacovigilance according to his activity (reporting adverse reactions, client objections, etc.) and participating in periodic organized training on the subject.
  • Observes the Company standards and policies. Shows professional behavior in relation with internal and external clients and takes into consideration the high level of demands of the company regarding the way he should treat the clients and other collaborators; Informs the management regarding any kind of abnormal situations noticed and propose solving solutions.
  • Be responsible for the way he uses the equipment, consuming goods and other instruments he uses that are the property of the Company.
  • Be responsible for observing the internal regulations regarding the occupational health and safety rules,
  • Observe the work performance criteria, as they are described in the Job Description; Observes the work procedures and provisions of the Internal Rules of Ceva.

 

WHY CEVA-PHYLAXIA?

  • We dedicate our work to protect animal welfare every day
  • We offer stable employment in a resilient industry
  • We offer comprehensive training opportunities
  • Our business has been growing exponentially
  • You can join a dynamic and enthusiastic team of professionals
  • You can gain unique expertise, exclusive in Hungary
  • Lunchtime is more enjoyable as it is included in working hours
     

COMPENSATION:

  • We acknowledge and value your performance with several benefits and bonuses in addition to your salary. We also believe in keeping our remuneration competitive and increasing our salaries annually.
  • We offer an exceptional annual cafeteria equivalent of a 13th month salary or above
  • You are eligible for an annual bonus scheme based on both individual and company performance.
  • We prioritize your wellbeing with an extensive health insurance package
  • We support your health with complimentary sports and fitness opportunities
  • We provide school starting support to assist your family
  • If you commute from Pest County by public transport, we will cover your travel
  • Enjoy a wide selection of breakfast and lunch options at discounted prices in our on-site restaurant
  • We offer free and secure parking for employees who commute by car
  • We have a Christmas bonus
  • Regardless of age, all employees are entitled to 25 annual vacation day
Budapest

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