At Adalvo, we're not just a company - we're a team of passionate people driven by our mission to consistently deliver high-quality products and services to our partners. We are positive, fast and always on target, we are Adalvo! 🎯 🚀

We are looking for an enthusiastic Responsible Person to join our dynamic Quality team. If you're someone who thrives in a fast-paced environment and loves tackling new challenges, then this is the perfect opportunity for you.

SUMMARY OF POSITION

This Responsible Person will support all functions and take decisions based on GDP guidelines, GMP guidelines and other relevant legislation with regards to the wholesale distribution activities for medicinal products and active pharmaceutical ingredients (APIs) and supports the Quality Management System of Adalvo Malta entities

RESPONSIBILITIES

Primary responsibilities of this role include the following:

Review and Approval of Technical Agreements with other parties, specifically those subcontracted for activities which impact GDP. Some roles in the Wholesale distribution process may be contracted out, such as but not limited to warehouse operations, transportation.
Ensure that appropriate standards of GDP in relation to the storage of medicinal products, including environmental parameters, are monitored in accordance with the requirements of the Wholesale Distribution License and as per EU and Maltese law. Audits of storage sites may be subcontracted. Maintenance and monitoring of the environmental parameters is delegated to the warehouse personnel and verified by the RP (or equivalent) at the subcontracted warehouse, where applicable.
Ensure that appropriate standards of GDP in relation to the transport of APIs and medicinal products are monitored in accordance with the requirements of the guidelines on principles of GDP of active substances and medicinal products for human use, as applicable.
Ensure that a Quality Management System is implemented at Adalvo Malta
Maintenance of the Quality System in line with GMP and GDP requirements.
Support the Adalvo Malta Qualified Person in batch certification by carrying out batch manufacturing record, batch packaging record and batch testing data review together with any relevant deviations, change controls and Out of specification records in compliance with required GMP standards and Marketing Authorisation requirements in line with Eudralex volume IV Annex 16.
Conducting Product Quality Reviews in support of batch certification.
Verify that valid Manufacturing and/or Wholesale Distribution Licenses are held by the suppliers and customers.
Ensure that suppliers and supply chain contractors have been qualified.
Verify that valid licenses for controlled substances are held by suppliers and customers in cases of distribution of narcotic and/or psychotropic medicinal products.
Actively participate in internal and external audits.
Ensure that relevant IT systems operated by Adalvo in support of supply chain activities are verified for their security and data integrity. This may be delegated to Adalvo Corporate IT.
Ensure that first expired - first out (FEFO) system is in place to manage storage and dispatch operations. This may be delegated to the QP and/or RP (or equivalent) located at the warehouse.
Ensure that the storage system segregates medicinal products with expired shelf life, damaged packages, or counterfeit products. This may be delegated to the QP and/or RP (or equivalent) located at the warehouse.
Ensure that assessment of returned medicinal products to saleable stock is duly carried out. This may be delegated to the QP and/or RP (or equivalent) located at the warehouse.
Assist with the preparation and approval of Standard Operating Procedures (SOPs) for activities related to quality management system, distribution of medicinal products and APIs and certification of medicinal products.
Participate in the company’s Quality Risk Management system and in the preparation of CAPA in response to external and internal audits and ensure their closure.
Keep abreast of the requirements and the latest trends in GDP/GMP and any other relevant guidelines.
Ensure that all personnel are trained in GDP & GMP requirements, and the risks of falsified medicines.
Provide wide-ranging support to the Adalvo Quality Team and other personnel in Quality and Operations as needed.
Participate in the management and investigation of complaints and recalls as well as returned, rejected or falsified products or APIs. This may be delegated to the customer’s/ storage site’s QP and/or RP (or equivalent).
Ensure compliance with the EU Directive on Falsified Medicines.
Participate in any other quality management activity that is reasonably requested by management.

QUALIFICATIONS & REQUIREMENTS

Education - University degree in pharmacy (minimum Bachelor’s degree). The person must not have been deprived of legal capacity to hold a position in the pharmaceutical industry.
Professional experience – preferably not less than 3 years of uninterrupted work experience in pharmacy activity or the production and/or control of pharmaceuticals.
To be well acquainted with the European standards on Good Distribution Practice (EU-GDP).
Good command of English.
Good computer skills.

CORE COMPETENCIES

Business Focus
Drive for Results
Building Team Spirit
Customer Service
Embracing Change
Quality

Why join us?

🎯 Exciting Challenges: Every day brings new opportunities to learn and grow.

🎯 Supportive Environment: We foster a culture of collaboration, where your ideas are valued, and your voice is heard.

🎯Career Development: We're committed to helping you reach your full potential through ongoing training and development opportunities.

🎯Recognizing Excellence: We recognize and appreciate hard work and dedication by offering competitive compensation packages and employee rewards programs that acknowledge contributions and achievements.

🎯Fun and Inclusive Culture: We believe in celebrating our successes and building strong connections within our team.

Ready to Ignite Your Passion?

If you're ready to take the next step in your career and join a business committed to consistently deliver high-quality products and services, then we want to hear from you! Send us your resume today!

Please be informed that only selected candidates will be contacted.

Responsible Person

Job Description