RQO Poland Responsible Person
RQO Poland Responsible Person
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Job Description
Purpose:
The purpose of the Regional Quality Officer (RQO) role is to act as the GDP Responsible Person for Poland and to operate Quality system in the territory (including Czech Republic Slovakia and Hungary) responsibility in full compliance and to represent CSL Behring (CSLB) Quality in the assigned affiliates/branch office or distributor markets as well as towards CSL Behring manufacturing sites QA and CSL Global Quality
QA (Quality Assurance) Support QA activities & Management
Implements and maintains the Quality Management System (QMS) in compliance with all regulations (international local) and Global CSL Behring standards in the assigned affiliates/branch offices or distributor markets
The quality activities include but are not limited to batch release change control complaints and deviation management.
Provides 3PLs/distributors vendor oversight and supports qualification selection and negotiation of new suppliers.
Supports new product launches and ensures compliance of the existing lifecycle products.
Acts as the primary point of contact to report or liaise about any recalls field actions or quality-related supply chain issues with batches delivered to the assigned affiliates/branch office or distributor markets.
Ensures that all relevant affiliate/branch office or distributor personnel receive relevant training in compliance with CSL Behring requirements and applicable regulations (including but not limited to relevant GxP trainings deviation and complaint management change control and label change management CSL Behring system and processes etc.).
Local engagement Cross-functional engagement
Participates in the local Commercial Operations Leadership Team meetings periodic business review meetings and provides input to strategic planning and discussions.
Primary point of contact to and from Global or Regional Quality ensuring a timely two-way communication above country and in market.
Collaborates with other affiliates and Global Quality group to benchmark best quality practices to mature quality culture for the affiliate the RQO is responsible for.
Main responsibilities:
Implementation and maintenance of the Quality Management System in compliance with local regulations and CSLB standards including but not limited to:
Deviation Management
Corrective Action & Preventive Action (CAPA) Management
Product Complaints Management
Change Control Management
Documentation Management
Training Management
Recall Management
Self-Inspection Management
Quality Risk Management
And recommendation for improvements to the quality system supporting CSLB business in the countries
Qualifications:
Degree in pharmacy or life science (if required by local legislation) or equivalent experience
At least 5-7 years of experience in the pharmaceutical industry of which 4 years of experience in Quality Management Systems and in warehouse management.
Fluent in local language in the assigned affiliates/branch office or distributor markets and good knowledge of oral and written English.
Understands and has experience in pharmaceutical quality assurance systems.
Knowledge of Good Distribution Practices (GDP) Good Manufacturing Practices (GMP) and local regulations and guidelines as applicable to the level of activities carried out at the affiliate or region.
Our Benefits
We encourage you to make your well-being a priority. Its important and so are you. Learn more about how we care at CSL.
About CSL Behring
CSL Behring operates one of the worlds largest plasma collection networks CSL Plasma. Our parent company CSL headquartered in Melbourne Australia employs 32000 people and delivers its lifesaving therapies to people in more than 100 countries.
We want CSL to reflect the world around us
At CSL Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy we are able to better understand and connect with our patients and donors foster strong relationships with our stakeholders and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging CSL
Do work that matters at CSL Behring!
Employment Type
Full-Time
