QA Manager QP

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, we are fast, we are always on target, we are Adalvo! 🎯 🚀

We are looking for a Quality Assurance Manager, QP to join our dynamic 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

The QA Manager, QP provides quality oversight for Adalvo activities involving medicinal products and active pharmaceutical ingredients, including oversight of suppliers, CMOs, service providers, distribution activities, quality systems, customer quality queries, audits, batch review and certification, and compliance with applicable GMP, GDP and legal requirements.

ORGANIZATION STRUCTURE

The Qualified Person will report directly to the SVP, Quality and will support various functions within the organization.

RESPONSIBILITIES

Primary responsibilities of this role include the following:

1. Maintain and support the Quality Management System in line with applicable GMP, GDP, internal procedures and relevant legislation.

2. Evaluate internal policies, principles, regulations, processes, controls and compliance with legislation and internal requirements.

3. Keep abreast of current EU-GMP, GDP and other relevant regulatory requirements and attend training where required.

4. Adhere to Adalvo corporate rules and procedures and maintain confidentiality in relation to role activities.

5. Provide quality oversight of CMO, service provider and subcontracted operations to ensure ongoing GMP and GDP compliance.

6. Approve, qualify and monitor manufacturing partners, control/testing facilities, active ingredient and excipient providers, packaging/material suppliers and supply chain contractors, as required.

7. Work with CMO/service provider operations to recommend quality and operational improvements where needed.

8. Liaise with CMO/service providers regarding changes that may impact registered dossiers and customer commitments.

9. Collect and review Product Quality Reviews from CMO/service providers for sharing with customers, as applicable.

10. Review, approve and/or sign technical agreements with third parties, including parties subcontracted for GDP or GMP impacting activities such as warehousing, transportation, manufacturing, testing or other service provider operations.

11. Ensure outsourced activities impacting product quality or distribution are appropriately controlled through qualification, agreements, oversight and follow-up.

12. Review batch manufacturing records, packaging records, analytical records, batch instructions, testing instructions and other relevant GMP documentation, as required.

13. Review investigations, deviations, change controls, complaints, OOS/OOT records and other records relevant to batch disposition and ongoing compliance.

14. Certify medicinal product batches produced by third parties to ensure compliance with marketing authorisations and applicable EU/Malta legal requirements prior to release to market.

15. Support QP declarations, batch release activities and decisions relating to blocking, withdrawal or other action for batches showing non-compliance with quality requirements.

16. Certify active substances, where required.

17. Ensure appropriate GDP standards are applied for storage of medicinal products, including monitoring of environmental parameters in accordance with wholesale distribution licence requirements and applicable EU/Maltese law.

18. Ensure appropriate GDP standards are applied for transport of APIs and medicinal products in accordance with applicable GDP principles.

19. Verify that suppliers and customers hold valid manufacturing, wholesale distribution and, where applicable, controlled substance licences.

20. Ensure storage systems segregate expired, damaged, rejected or suspected counterfeit products and that assessments of returned products to saleable stock are duly performed.

21. Ensure compliance with the EU Directive on Falsified Medicines and support controls against falsified medicines across relevant activities.

22. Manage or participate in investigations of deviations, complaints, returned, rejected, falsified or non-compliant products or APIs, including events related to distribution and third-party manufacturing activities.

23. Prepare, review, monitor and evaluate corrective and preventive actions arising from deviations, complaints, audits, inspections and quality events, and ensure closure.

24. Participate in quality risk management activities and support quality risk assessments as required.

25. Organise, conduct and support internal audits, self-inspections, customer audits, external audits and regulatory inspections in accordance with GMP and GDP standards.

26. Prepare audit reports, including findings, recommendations and required corrective actions, and submit/share reports internally as required.

27. Monitor audit corrective actions through to completion and support inspection response/CAPA programmes following regulatory, customer or external inspections.

28. Prepare, review and approve SOPs related to the Quality Management System, distribution, batch release, certification and other Adalvo activities.

29. Support training of personnel on GMP, GDP and falsified medicines risks and monitor training plans for GMP/GDP compliance.

30. Ensure relevant IT systems supporting supply chain activities are verified for security and data integrity, as applicable.

31. Manage quality-related queries and demands from Adalvo customers and ensure timely, appropriate and efficient responses.

32. Respond to quality inquiries and provide wide-ranging support to Quality, Operations and other functions as needed.

33. Participate in management meetings and prepare reports related to the maintenance and control of Adalvo quality systems.

34. Participate in any other quality management activity reasonably requested by management.

QUALIFICATIONS & REQUIREMENTS

• Education - University degree in Pharmacy (minimum Bachelor’s degree).

• Professional experience – preferably not less than 3 years of uninterrupted work experience in pharmaceutical companies with focus on distribution and Quality Management System.

• To be well acquainted with the European standards on Good Distribution Practice (EU-GDP).

• Good knowledge of SAP, Salesforce, DotCompliance systems and Serialization

• Good command of English.

• Good computer skills.

• Eligible for being registered as Qualified Person

CORE COMPETENCIES

Quality

Business Focus

Drive for Results

Building Team Spirit

Customer Service

Embracing Change

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!