Descrizione del lavoro:
Quality Operations Manager
* Performing the qualification of imported medicinal products targeted for the Hungarian and the regional market entering and leaving the warehouse of GlaxoSmithKline-Consumer Kft. in Budaörs.
* Professional supervision of manufacturing and wholesale distribution activity in line with currently prevailing provisions authority (OGYEI) requirements, GDP/GMP guidelines and the enforcement of such provisions.
* Performing the duties and responsibilities of the Qualified Person and Responsible Person stipulated within ESZCSM Regulation no. 39/2004 (IV.26).
* Reports to Quality Lead.
* Job location - Budapest, Hungary.
* Maintenance and development of the Company's Quality assurance system.
* Liaison with National Institute of Pharmacy and Nutrition (in Hungarian: OGYEI) as Responsible Person/Qualified Person.
* Evaluation and approval of Technical Terms of Supply (TTS), Quality Assurance Agreements.
* Coordination of wholesale distribution and manufacturing activity.
* Management of authorized activities and the accuracy and quality of records.
* GDP/ GMP trainings and performance monitoring.
* Coordination and promptly performance of any recall operations for medicinal products.
* Proposal and if necessary, decision-making in respect of the final destination of returned, rejected and counterfeited products.
* Handling of customer complaints system and product recalls handling regarding the quality of products marketed in Hungary and on the regional market.
* Responsible for reporting of quality defects of any authorized medicinal products or of its bath number to the Quality Lead and competent authority (OGYEI in Hungary).
* Complaint handling to the manufacturer or supplier on defective quality items.
* Batch certification for further use and shipment as Responsible Person.
* Conducting third party audits.
* Release of products received in the warehouse in compliant with the relevant regulations, with support of necessary information.
* Preparation and / or approval of the warehouse operation policies.
* Keeping contact with the Company's Europe Quality Division.
* Management of change controls related to warehousing, distribution and QMS
* Performance of correctional or preventive actions (CAPA).
* Performance of Deviation Management and Root Cause Analysis.
The successful candidate:
* Degree in Pharmacy or equivalent.
* Qualified Person certification issued by Hungarian Health Authority (at least 2 years of experience) is a must; Responsible Person certification is considered an asset.
* Relevant 5 years' experience in Quality Systems & Quality Operations within Pharmaceutical Industry (manufacturing sites, distributors and/or wholesalers intern/national companies (GMP & GDP).
* Good related legislation knowledge.
* Experience in medical devices, food supplements, cosmetics.
* Good analyser.
* Able to stick to the standard and not be pressurized.
* Concise and persuasive in the description of the different QA situations.
* Works with a spirit of continuous improvement and innovation, creatively open to new ideas and methods.
* Good team player and communication skills.
* Motivated and inspiring others.
* Handling complexity effectively.
* Excellent oral and written communication skills in English & Hungarian.
Why (COMPANY NAME)?
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As (COMPANY NAME) focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
* Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
* Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
* Continuously looking for opportunities to learn, build skills and share learning.
* Sustaining energy and well-being.
* Building strong relationships and collaboration, honest and open conversations.
* Budgeting and cost-consciousness.
If you require an accommodation or other assistance to apply for a job at (COMPANY NAME), please contact the (COMPANY NAME) Service Centre at 1-xxx-xxx-xxx7 (US Toll Free) or +1 xxx xxx xxx5 (outside US).
(COMPANY NAME) is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
Important notice to Employment businesses/ Agencies
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Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, (COMPANY NAME) may be required to capture and report expenses (COMPANY NAME) incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure (COMPANY NAME)'s compliance to all federal and state US Transparency requirements. For more information, please visit (COMPANY NAME)'s Transparency Reporting For the Record site