We are looking for a colleague who will join the strong, and dynamic Quality Department as Responsible Person Deputy & Quality Specialist. The position has the opportunity to perform a key role in the company's strategic development plan and requires a high level of collaboration with all MagnaPharms’ departments.
- Perform Good Distribution Practice and Quality Assurance activities in line with national and European regulations for Medicinal Products, Medical Devices, Food Supplements, Foods for special medical purposes, Cosmetics, Accessories;
- Responds to the needs of partners and health authorities, establishes strong professional relationships, and provides credible Good Distribution Practice expertise;
- Monitoring and ensuring the fulfillment of local and European legal regulations and standards such as LawGood Distribution Practice Regulation, ISO 9001:2015 Standard, etc.
- Maintaining and improving MagnaPharm’s quality system by managing and reviewing standard operating procedures and by establishing initial and continuous training programs;
- Applying Quality Risk Management (QRM) principles and supporting the Quality Manager in the Deviations, CAPA’s, and Change Control Management;
- Supporting the Responsible Person by ensuring that appropriate quality GDP systems are in place, such as customer and supplier screening, quality agreements, recall operations, management of product and distribution complaints, the decision of the final disposition of returned, rejected, recalled, or falsified products and the approval of any subcontracted activities which may impact on distribution;
- Ensuring along with the Responsible Person that the subcontracted operations (logistic and transport services) are qualified and audited and that they do not compromise the quality of MAGNAPHARM’s distributed medical products portfolio;
- Supporting the self-inspection program by checking that the appropriate regular established intervals are followed, and necessary corrective measures are in place;
- Focusing on the management of authorized activities and the records’ quality and accuracy;
- Establishing and maintaining good communication with health authorities;
- Ensuring the maintenance and updating of MagnaPharm’s GDP Authorization and Certificate, in accordance with the company's global strategy and local regulations;
- Identifying the need for new standard operational procedures (SoPs) and participating in developing, preparation and implementation of them.
- University degree in Pharmacy;
- Minimum 1 year experience in Good Distribution Practice and Quality Assurance Management, preferably as Responsible Person or Responsible Person Deputy;
- Strong knowledge of Good Distribution Practices and Quality Management principles;
- Experience working with local Health Authorities;
- Computer-proficient performer with expertise in Microsoft Office (Word, Excel, Power Point, Outlook etc.), database management system, etc.
- Very good in English speaking & reading & writing;
- Clear and concise written and verbal communication skills, assimilation and synthesis capacity, discipline, willingness to share the knowledge with collaborators;
- Resourceful, creative problem-solver a positive attitude towards analyzing and offering solutions;
- Excellent team player, who listens, thrives on collaborating with team members;
- Problem solving skills based on science, facts data and understanding of the regulatory requirements;
- Able to manage challenging conversations and handle objections;
- Highly motivated and self-directed with the ability to plan, manage and prioritize multiple projects independently; demonstrates resilience and flexibility.