Quality and Regulatory Affairs Specialist (maternity cover) - 2406162944W

　　Description

　　J&J Innovative Medicine (Janssen) is recruiting for a Quality and Regulatory Affairs Specialist (fixed-term contract for a maternity cover) to be located in Bratislava.

　　The Quality Specialist is responsible for following quality procedures and processes and maintaining relevant documentation. Is responsible for compliance with the relevant legislation and provides support in obtaining and maintaining licenses for the wholesale distribution of medicinal products and for the handling of narcotic and psychotropic substances. In connection with these licenses, acts and appears as a Responsible Person.

　　Under the supervision of the Head of RA (i.e. Regulatory Affairs), the Regulatory Affairs Specialist is responsible for regulatory activities carried out to support and develop the company in accordance with its goals. This includes support in obtaining and maintaining marketing authorizations, participating in the new product introduction to the market and extension of registration to include new indications and ensuring compliance with local and EU legislation.

　　MAIN ACTIVITIES/TASKS:

　　1. QUALITY SPECIALIST

　　Maintains the Quality System in accordance with the company's Quality Manual, in accordance with the regional Commercial Quality (CQ) strategy and the LOC business strategy.

　　Actively collaborates with other departments to ensure quality activities related to new medicinal product launches, medicinal product cessation or disposal/destruction and to ensure alignment of quality initiatives with the company's strategic direction.

　　Prepares, updates and approves relevant SOPs.

　　Responsible for updating data in databases.

　　Creates and updates product list of locally marketed medicinal products.

　　Prepares documents for the Quality System Management Review.

　　Performs tasks in the change control management process, implements requirements for managing the life cycle of documents and records.

　　2. RESPONSIBLE PERSON

　　As a responsible person is responsible for Good Distribution Practice in the warehouse according to the relevant Slovak and European legislation (Act No. 362/2011 Coll. Act on Medicines and Medical Devices and on Amendments to Certain Acts, Act No. 139/1998 Coll. Act on Narcotic Substances, Psychotropic Substances and Preparations as amended, Decree No. 128/2012 Coll.., on the requirements for good manufacture practice and good distribution practice, as amended, Decree no.158/2010 Coll. Decree of the Ministry of Health of the Slovak Republic on the details of the book of narcotic substances and on the registration of documents proving the inbound and outbound of narcotic substances and psychotropic substances, Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products Text with EEA relevance, Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use Text with EEA relevance 2013/C 343/01).

　　As a Responsible Person for the handling of narcotic and psychotropic substances (OPL), is responsible for their receipt, storage and distribution according to the relevant Slovak and European legislation.

　　As a Responsible Person, has the authority to make decisions regarding her/his duties.

　　Is responsible for updating local licenses for wholesale distribution of human medicinal products and for handling OPL in accordance with relevant local legislation.

　　Is responsible for the release of delivered medicinal product batches to the Slovak market.

　　Prepares documents for the release of delivered medicinal product batches on the Slovak market.

　　Is responsible for ensuring that all delivered medicinal products are packed in current artworks approved by the SIDC, checks the certificates of analysis of delivered medicinal product batches and temperature records.

　　In the case of an OPL, shall ensure that the activities are carried out in accordance with the specific requirements applicable to the OPL.

　　Assesses and releases returned medicinal products back to the distribution.

　　Together with the warehouse staff, carries out an inventory of OPL status and stock status.

　　Supervises all activities related to OPL.

　　Prepares required reports for SIDC and MoH based on legislative requirements.

　　Participates in the coordination of activities related to medicinal product recall from the market, fulfills tasks during the recall of non-compliant batches from the market.

　　Performs tasks in approving suppliers and customers and approves all subcontracting activities that may affect GDP.

　　Approves disposal of returned, rejected, recalled, or counterfeit products.

　　Performs tasks in ensuring the quality of the medicinal products and trains relevant personnel.

　　Is responsible for the preparation of the training plan for employees and for their retraining according to this plan in accordance with the training matrix, i.e. is responsible for the initial and ongoing training of employees in the area of quality, updates the training matrix.

　　Resolves product quality complaints and helps in resolving logistics and marketing complaints.

　　In cooperation with the Local Safety Officer, resolves product complaints related to adverse events.

　　Supervises compliance with the cold chain regime of medicinal products.

　　Supervises the storage of retention samples.

　　Prepares documents and accompanies inspections of state authorities or company auditors, participates in the addressing of necessary corrective/preventive measures.

　　Keeps records of all delegated tasks.

　　Monitors applicable legislation, including any legislation / guidance relating to OPL.

　　Monitors the websites of public health authorities for any new information related to quality issues.

　　Regularly educates herself/himself in the field of good distribution practice and quality.

　　Performs other tasks and duties established by the direct supervisor.

　　3. REGULATORY AFFAIRS SPECIALIST

　　Management of the department

　　Maintenance of local documentation of medicinal products in accordance with current documentation policies concerning marketing authorizations according to relevant local and EU legislation.

　　Archive RA documentation.

　　New and existing drugs

　　Preparation and submission of marketing authorization applications medicinal products with the support of central registration functions.

　　Responsibility for compliance with project deadlines or their escalation toward the RA head.

　　Participation in internal working groups as needed and addressing any regulatory activities with colleagues from the RA department.

　　Maintenance of product information, including labeling on the packaging, in accordance with the current approved files concerning marketing authorizations according to the relevant local and EU legislation.

　　Responsibility for the management of packaging components.

　　Compliance

　　Compliance with all regulatory requirements (e.g. timely submission of documentation, timely implementation of new national and international legislation, timely implementation and training under SOPs and support systems).

　　Maintaining awareness of regulatory directives/guidelines/national requirements.

　　Internal contacts

　　Support of other departments based on their needs (logistics, quality, pricing, marketing, medical, commercial).

　　Support in case of company interest to participate in the tender.

　　External contacts

　　Ensuring positive interaction in any communication with the State Institute for Drug Control, both generally and in matters related to the medicinal products.Others

　　Support and contribution to GRA-EMEA initiatives.

　　Contributing to knowledge-based initiatives and change management to increase efficiency.

　　Activities related to the updating of medicinal product packaging components.

　　4. GENERAL RESPONSIBILITIES

　　Meeting all relevant quality and compliance requirements (i.e. HCC/HCBI/ANTI-CORRUPTION/FCPA/US-GCC/Privacy/SOX/QA/Safe Fleet).

　　Timely reporting of spontaneous adverse events and product quality complaints for all company medicinal products.

　　Successful and timely completion of all mandatory trainings.

　　Qualifications

　　Ability to speak English and national languages fluently.

　　Completed university education in the field of pharmacy and adequate competence and knowledge to perform the task of responsible person for good distribution practice and handling of narcotic and psychotropic substances in accordance with relevant local legislation.

　　Legal capacity, clean record, medical capacity.

　　Category B driving license.

　　Knowledge of MS Office.

　　Responsibility, self-reliance, flexibility, and willingness to learn new things.

　　Ability and willingness of high work engagement.

　　The ability to work precisely, without errors of a formal and factual nature and systematically

　　Resistance to stress, excellent communication skills, ability to solve problems.

　　For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

　　We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.

　　That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

　　Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!

　　Primary Location Europe/Middle East/Africa-Slovakia-Bratislava-Bratislava

　　Organization Johnson & Johnson Slovakia, spol. s.r.o (7067)

　　Job Function Regulatory Affairs

　　Req ID: 2406162944W