- Księstwa Łowickiego 12, 99-420 Łyszkowice, PolskaŁyszkowice (pow. łowicki), łódzkie
- Ogłoszenie wygasło 23 dni temu
- Pełny etat
- Specjalista (Mid / Regular)
The objective of the position is to perform the monitoring and control function to ensure the compliance with applicable policies, instructions, guidelines, local and international laws and regulations of the pharmaceutical industry.
As Head of Quality Compliance department in the Quality Unit, the job holder is responsible for:
- Management and organization of the work of a team of specialists.
- Ensuring and improving the quality management system.
- Preparation and maintenance of Standard Operating Procedures (SOPs) relating to the area of responsibility.
- Maintenance of GMP documents in the field.
- Conducting internal audits.
- Preparation, implementation, evaluation and follow-up of the Quality Council.
- Provide information to the management on quality-relevant topics.
- Reporting quality-relevant Key Performance Indicators (KPI's) within the Quality Unit.
- Complaints management, which includes the collection, investigation and evaluation of the quality defects of drugs manufactured on site.
- Management of the Product Quality Review process.
- Management of the communication and investigation process of quality incidents, including recalls.
- Management of Health Authorities Inspections and external audits, including preparation, hosting and management of post-audit activities.
- Management of CAPA process at site
Skills and Competencies:
- Strong influencing, motivational, interpersonal and relationship building skills at all levels.
- Excellent written and oral communication skills.
- Ability to think strategically and enterprise wide to ensure compliance and business needs are met or exceeded.
- Strong decision-making skills.
- Negotiation skills, effective collaboration and ability to anticipate needs and requirements.
- Ability to speak up and focus management attention in case of potential question marks.
- People management and development skills.
- Strong general computer literacy with Intermediate skills in Microsoft Word, Excel, Power Point and Outlook.
Experience and Education:
- Master's Degree in Chemistry, Pharmacy, Biotechnology, other technical/scientific area.
- 5-8 years’ experience in quality assurance, operations, regulatory or relevant experience. Some supervisory/management experience preferred.
- Knowledge of quality management systems and GxP compliance requirements including regulations and standards affecting device and pharmaceutical products.
- Advanced English.
- Our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – guide how we work and can be felt across every department
- We take actions and make decisions by focusing on patient-centricity; your contribution will make an impact on people’s lives and change futures every day
- We take care about our employees and offer: interesting work in an international environment, the opportunity for self-development, stable employment conditions, benefit package (group insurance, private medical care, co-financing meals in the canteen)
Empowering Our People to Shine