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 looking for an enthusiastic Quality Assurance Manager to join our dynamic Adalvo team. This position offers an opportunity for well-suited candidates to join a growing, fast-paced energetic environment and culture.
SUMMARY OF POSITION
This position calls for an ambitious individual who is able to provide support to the Quality Assurance Team at Adalvo with respect to the quality oversight of third-party contract manufacturing organizations and other service providers to ensure compliance with applicable regulatory requirements. This position will also manage all Adalvo customer quality-related demands and queries and ensure that these are addressed appropriately.
ORGANIZATION STRUCTURE
This position will report directly to the Quality Director.
RESPONSIBILITIES
1. Provide oversight and management of the Quality Assurance activities related to CMO/service provider operations to ensure GMP (Good Manufacturing Practice) and GDP (Good Distribution Practice) compliance.
2. Review and approve batch instructions, testing instructions, change controls, deviations, complaints, out-of-specification (OOS) and out-of-trend (OOT) records, investigations, and other necessary GMP and GDP documents for activities related to CMO/service provider operational activities.
3. Work closely with CMO/service provider operations and recommend quality and operational improvements as needed, to ensure that all operations comply with all regulatory requirements and product quality, safety, and efficacy for intended markets.
4. Monitor and report the effectiveness of the Quality Management System at CMO/service providers through key performance indicators.
5. Liaise with CMO/service providers in the communication of changes impacting registered dossiers to Adalvo customers.
6. Collect and review Product Quality Reviews (PQRs) from CMO/service providers to be shared with customers.
7. Manage quality-related queries/demands arising from Adalvo customers to ensure that queries/demands are addressed efficiently and provide the best customer quality service.
8. Review and sign Technical Agreements with 3rd Parties as required.
9. Assist with new product introduction and technology transfer and support registrations.
10. Support training of personnel on GMP and GDP and monitor people's training plans for GMP and GDP compliance.
11. Assist the Quality Assurance team through any required regulatory, customer, and external audits.
12. Support in the preparation of programs for corrective and preventative actions (CAPA) after inspections conducted by regulatory bodies, customers, and other external organizations.
13. Support in the qualification of manufacturing and control activities at contract manufacturers and testing facilities, through audits, or other means, including due diligence work as required.
14. Follow up on any Corrective Actions from audits and ensure they are closed out.
15. Support the QPs in preparation of the QP Declarations, release of batches, and in the process of blocking withdrawal from the market of batches which showed non-compliance with the quality requirements.
16. Support the Quality Assurance department in the conduct of quality risk assessments.
17. Assist with the preparation and approval of Standard Operating Procedures (SOPs) for activities related to Adalvo.
18. Ensure compliance with the EU Directive for Falsified Medicines.
19. Any other quality management activity that is reasonably requested by management.
QUALIFICATIONS & REQUIREMENTS
1. Education - University degree in pharmacy, chemistry or another science-based discipline (minimum Bachelor's degree). The person must not have been deprived of legal capacity to hold a position in the pharmaceutical industry.
2. Professional experience – preferably not less than 5 years of work experience in the production and/or control of oral dosage forms and injectables.
3. To be well acquainted with the European standards on Good Manufacturing Practice (EU-GMP) and Good Distribution Practice (GDP), as well as other international GMP standards.
4. Good command of English.
5. Good computer skills.
6. Willingness to travel to visit CMO/service providers.
CORE COMPETENCIES
1. Quality Operations
2. Audits, regulatory inspections
3. Manufacturing and testing of injectables
4. Business Focus
5. Drive for Results
6. Building Team Spirit
7. Customer Service
8. Embracing Change
Why join us?
1. Exciting Challenges: Every day brings new opportunities to learn and grow.
2. Supportive Environment: We foster a culture of collaboration, where your ideas are valued, and your voice is heard.
3. Career Development: We're committed to helping you reach your full potential through ongoing training and development opportunities.
4. Recognizing Excellence: We recognize and appreciate hard work and dedication by offering competitive compensation packages and employee rewards programs that acknowledge contributions and achievements.
5. 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 delivering 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.
#J-18808-Ljbffr