Quality compliance specialist

Responsibilities:

  • Professional tasks shall be executed in accordance with the current Hungarian, international (OGYÉI, FDA, ICH , etc.) and company requirements and rules
  • Maintain and develop detailed, comprehensive and well-structured Quality Documents (cGMP & GDP)
  • Act as Training Superuser (managing the training plans in LMS and monitoring the relevant KPIs at site level)
  • Provide specific trainings in her fields (certified trainer) and act as a driver in training management in coperation with the departmental leaders and training responsibles especially for GMP related trainings
  • Participate on Audits (Customer, Authorities, Suppliers)
  • Works closely with Quality Control (Change Control, CAPA), preparation of the Annual Product Review (APR) as CQA.
  • Elaborate validation/qualification annual plans and evaluate the execution of validation/qualification works within the confines of annual product review (APR)
  • Check documents of IT systems related to qualification (URS, PQ) in English handling and reviewing of DQ, IQ, OQ, PQ documents

Requirements:

  • Engineer or pharmacist, life sciences, chemistry, biology or related field Msc degree
  • Minimum of 2 years Quality experience in biopharmaceutical/pharmaceutical or related industry
  • Professional English knowledge (oral and written, both of them are need!)
  • Excellent communication, organizational and teamwork skills
  • Detailed oriented person, who has ability to multi-task, prioritize work load and work independently to meet commitments with minimal supervision
  • Computer skills in word processing, spreadsheets and databases (TrackWise, Minitab would be an advantage.)
  • Analyzing Information, Reporting Results, Technical Understanding, Promoting Quality Process Improvement, Developing Standards, Managing Processes, Supports Innovation

Advantage:

  • Expert of TrackWise system
  • Expert of e-learning/Training management systems
  • Expert of customer audit and internal audit.

Benefits:

  • Attractive compensation package
  • Challenging job in the international pharmaceutical business
  • Long term employment
  • Good working 'nordic style' atmosphere

Sector(s):

  • Engineer
  • Quality Assurance Engineer
  • Healthcare, Pharmaceutical Industry
  • Quality Assurance
  • Full time

Experience required:

  • 1-3 years professional experience

Required language level:

  • English - intermediate / communication

Job location:

Budapest

How to apply/ contact information:

Xellia Pharmaceuticals is owned by Novo Holding A/S and is a specialty pharmaceutical company leading in the development, manufacture and supply of anti-infective treatments. Headquartered in Copenhagen, Denmark, Xellia has global facilities in Europe, North America, and Asia, currently employing over 1700 people. With over 100 years of industry experience in developing last resort treatments for infectious diseases, Xellia is focused on the supply of products which not only save lives, but also improve and enhance patients’ quality of life. Together with us, you can help lead the fight against bacterial infections.