Quality Manager and Responsible person
Our client is one of a largest and fast-growing pharmaceutical company on the market offering wide portfolio of medicines, medical instruments and OTC products.
For their local team in Sofia, we are looking for an enthusiastic, self-reliant and dedicated to achieving the best performance
Quality Manager and Responsible personThe role of a Quality Manager and Responsible person (QM&RP) is to lead on the Quality Assurance Framework to create a culture of continual learning and development.
The QM&RP is responsible for ensuring that the company’s QMS systems in Bulgaria meet all relevant local and international requlations (GDP, GMP, ISO 9001), Partner’s requirements and corporate standards.
Specific areas of support may include Storage and Distribution, potential quality events/complaints management activities, Suppliers and Customers qualification Controls, Risk Management,Health Agency inspections/internal audits, CAPA, and overall Quality Manual requirements. This position will ensure that all product, process, or system related quality activities supporting the business at the affiliate from products receiving through distribution are in compliance with corporate, governmental, and local regulations and requirements.
Your responsibilities include, but not limited to:- Leading local execution of quality systems including compliance to EU GDP and EU GxP requirements (requiring knowledge of regulations) as well as local work practices
- Monitor CAPA implementations and effectiveness
- Perform routine risk/impact evaluations associated with product based decisions or the quality system and participate in escalation situations
- Provide effective system for complaint management activities, withdrawal, suspected falsified medicinal products, and the like
- Coordinate activities in the event of a product Recall and mock recall
- Partake and support internal and external audits to assess compliance
- Verify that medicinal products are taken and distributed only from authorized entities/customers
- Responsible for the quality of products released onto the market
- Perform release for distribution of product batches
- Accountable for the process of additional labelling of products
- Ensure efficient information flow and effective communication of all relevant quality matters within the country organisation, from the country to the Corporate QA Manager and vice-versa including but not limited to issue escalation
- Ensure all GDP/GMP operational activities are implemented, maintained and continuously improved in accordance with all internal guidance, external regulations and in line with best practice. Keep up to date with changes/ updates in legislation via Bulgarian Health Authority websites and/or newsletters, and any directive regulations or guidelines
- Act as Responsible Person and fulfill duties defined by National Health Authority and company global Procedures.
- University Degree in Pharmacy (strong adv.)
- 3+ years’ experience in quality assurance, quality oversight or relevant experience.
- Knowledge in as many of the following areas as possible: QMS, Quality Risk Management, Data Integrity, and EU GxP, MDR regulation, Pharmaceutical industry standards
- Relevant knowledge and experience related to the distribution of medicinal products
- Flexible to commute across all company’s facilities in Sofia
- Ability to multitask
- Effective communication and interpersonal skills
- Excellent attention to detail with strong analytical skills
- Ability to work independently and collaboratively across multiple cross-functional teams
- Proficiency in English.
- Well-developed computer skills
Should you find this job attractive, please send us your CV in English.
Only short-listed candidates will be contacted.
All applications will be treated with strict confidentiality.
People Solutions Factory has an unlimited License № 2052/31.05.2016 for providing human resources services.
от 4300 до 5300 лв.
