BrightOwl Loader Loading

Responsible Person/QA Manager (part-time) - Romania  

Company managed [?] Still accepting applications

Posted on : 01 May 2017

Project Description

Description:
  • We aspire to be the patient-preferred global biopharmaceutical leader, transforming the lives of people with severe diseases, and need exceptional individuals to achieve this goal. 
  • We are looking for enthusiastic and talented professionals who thrive on challenge and change, who want to make a difference and deliver results. 
  • At the earliest date possible we search in Romania to further strengthen our Quality Assurance function for a Responsible Person.

  
Job responsibilities:   
  • Ensure that all aspects of the handling and distribution of pharmaceutical products comply with the requirements of the EU Good Manufacturing Practices / Good Distribution Practices and relevant local regulatory and legislative requirements. 
  • Ensure, in collaboration with Quality Leader, the implementation, maintenance and upgrading of the local Quality System in order to drive compliance with local/International GDP regulatory requirements and our company global standard operating procedures 
  • Participate and provide feedback during  periodic Management Review of Quality Systems 
  • Assure that gaps identified through KQI's are addressed appropriately in order to mitigate risk and escalate critical trends to Quality Leader. 
  • Ensure that coordinated contact is maintained with the local Regulatory Authorities and the local partners (pre-wholesaler, Swiss importer / EU release site, suppliers, third parties, l and distributors) 
  • Provide quality oversight to local GDP vendors particularly such as warehouse/distribution service providers in compliance with company  Quality Standards (qualification, quality agreements, vendor management) 
  • Ensure Affiliate readiness for GDP regulatory inspections 
  • Ensure that any GDP-related deficiencies identified through audits or other means are addressed through the timely implementation of effective appropriate corrective and preventive actions 
  • Provide adequate input through the relevant quality plan and budget process to make sure adequate quality resources are available 
  • Ensure that Quality deliverables are completed in a timely manner in accordance with Global SOPs (e.g. follow up and closure on all relevant complaints, deviations and CAPAs, change controls) 
  • Participate to the execution of local recalls following the global recall process 
  • Support Global projects on quality systems as requested 
  • Ensure inter-site quality agreements with Global QA and local vendors, and the associated appendices, are established, complete, and up to date 
  • Ensure compliance to GDP and shipping conditions, and drive a QA decision on the disposition of the product 
  • Ensure that all drug products are released to the market in accordance with the marketing authorizations and in accordance with local regulations 
  • Ensure that a local Quality System and Standard Operating Procedures are in place for all GDP related activities and that compliance is maintained through training and internal audits 
  • Contribute to the creation of written procedures to handle critical areas such as quality complaints, product recalls, third party warehouse management, trainings, etc. 
  • Establish good working relationship with the Logistics representatives with special emphasis on providing / receiving information on regulatory changes, product flow changes etc. 
  • Negotiate with the Health (Drug Regulatory) Authority in the topics responsible for 
  • Ensure appropriate communication in quality related matters e.g. quality complaints, potential product recalls or recalls 
  • Audit, evaluate, supervise and co-ordinate local third party activities in GDP / GMP matters and ensure that third party warehousing, (re-) packaging, and / or distribution activities are in compliance with European, local and in­ house standards 
  • Provide professional input to define and manage GDP related risks in the affiliate.  
  

Experience:   
  • Minimum of 10 years working in the pharmaceutical industry in a quality management position 
  • Responsible person should meet the qualification and all conditions provided for by the local and EU regulation (superior scientific profile preferred (PharmD)) 
  • Operational GMP experience would be a distinct advantage 
  • Experience interacting with regulatory bodies and third party organisations with respect to QA systems and regulatory inspection preparation.  
  


Specific skills:   
  • Solid knowledge of relevant legal requirements and international guidelines of the pharmaceutical industry, including the interpretation and practical implementation of applicable regulations 
  • Possess good auditing capabilities and skills 
  • A team player with the ability to work with autonomy and handle complex/difficult situations   
  • Good interpersonal, verbal, and written communication skills.   
    

Job Segment:  Law, Pharmaceutical, QA, Quality Assurance, Legal, Science, Quality, Technology