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 an enthusiastic Quality Assurance Operations Managerto join our dynamic Adalvo team. This position offers an opportunity to 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 Operations team at Adalvo with respect to the quality oversight of third party contract manufacturing organizations, API suppliers and other service providers to ensure compliance with applicable regulatory requirements.

RESPONSIBILITIES

Primary responsibilities of this role include the following:

Execute quality audits at Suppliers\CDMOs and guarantee the implementation of the agreed CAPA plan
Negotiate Quality Agreements with Suppliers\CDMOs
Support Suppliers\CDMOs with Regulatory Inspection preparation
Contribute to Suppliers\CDMOs development with GMP training and coaching
Review and approve all the quality documentation related to the development projects and\or the Technology Transfers like:
Raw materials and Finished Products specifications
Master Batch Record
Process Validation Plan\Protocol\Report
Executed Batch Records
Cleaning Validation
Packaging Validation
Nitrosamines and elemental impurities Risk Assessments
Elemental Impurities Assessment
Aseptic Process Simulation (APS) Protocol\Report
Analytical methods validation and transfers
Change Control
OOS\Deviations
Any other document related to the manufacturing and testing of the product in scope
Support due diligences for the evaluation of new product dossier/partners as relevant to the scope of role function
Perform oversight and management of the Quality Assurance activities related to CDMO/service provider operations to ensure GMP (Good Manufacturing Practice) and GDP (Good Distribution Practice) compliance.
Assist in preparation/negotiation of Quality Agreements with 3rd parties as required.
Continuously evaluate CDMO/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.
Keep abreast of the requirements and the latest trends in GMP, GDP and other regulatory requirements and attend suitable training as required.
Monitor and report the effectiveness of the Quality Management System at CMO/Service provider.
Work closely with all other Adalvo Teams worldwide as required.
Support training of personnel on GMP and GDP
Promote a quality culture throughout the organization.
Assist in the management of budgets for the Quality Organization.
Support the Quality Assurance department in the conduct of quality risk assessments.
Support any other quality management activity that is reasonably requested by management.

QUALIFICATIONS & REQUIREMENTS

Education - University degree in pharmacy, chemistry or another science based discipline (minimum Bachelor’s degree).
Professional experience – preferably not less than 8 years of work experience in the production and/or control of pharmaceuticals.
Well acquainted with the European standards on Good Manufacturing Practice (EU-GMP) and Good Distribution Practice
(GDP) as well as other international GMP standards.
Experience with Regulatory Inspections EMA, FDA, Russia, ANVISA, etc.
Experience with oral dosage forms (tablets, capsules, etc.) and injectables
Experience in conducting audits
The person must not have been deprived of legal capacity to hold a position in the pharmaceutical industry.
Good command of English.
Good computer skills

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.

Quality Assurance Operations Manager

Job Description