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