CMC & Technical Quality Systems Manager
Job ID: JOB-12305
JOB ID: JOB-12305
CMC & Technical Quality Systems Manager
Permament in Cork
Finding the right company that aligns to your career aspirations and values is so important. It’s worth taking the time to get this right.
This CMC & Technical Quality Systems Manager opportunity located in Cork is one of those stand out positions that don’t come along every day.
Let us tell you more….
Our Cork based Client are recruiting for a Quality Systems Manager to join their team on a permanent basis. The primary focus of this role is providing Chemistry and Manufacturing Controls (CMC) expertise for the Pharmaceutical Quality System (PQS) and leading the Technical Quality function
- Leadership of the CMC and Technical Quality function for Pharmaceutical Products to include API’s, Commercial products, and Clinical supply products. This will include the support of the strategy for Process and Analytical method development for the active pharmaceutical ingredient (API), excipients, Pharmaceutical products, and the Design assurance process for the medical device elements of the Pharmaceutical led combination products.
- Support in the development, management and compliance of the Pharmaceutical Development process and procedures in alignment with the Pharmaceutical Regulatory requirements.
- For the processes lead by the CMC and Technical Quality function ensure the PQS is compliant to ICH (Q8, Q9 and Q12A.) and the GMP’s of all pharmaceutical and combination products regulatory agencies (e.g., FDA, EU,PICs )
- Governance of the Risk management process for Pharmaceutical products in accordance with the PQS, which includes the control of the critical process parameters (CPP’s), critical quality attributes (CQA’s) and PFMEA documentation by facilitating cross-functioning planning of activities.
- Supporting regulatory submissions (Investigational New Drug Applications (IND), Investigational Medicinal Product Dossier (IMPD), new drug application (NDA), Biologics License Application (BLA)), including preparing CMC sections, Product Stability program strategy and ownership of post market commitments.
- Support Project management in the development of the timelines and budgets for CMC and Quality technical projects including timing of the submissions in conjunction with Regulatory
- Support Pharmaceutical Products complaint investigations.
- Support the Pharmaceutical Production Unit process improvements and optimisations to assure robust and scaleable manufacturing processes that meet product target profile/specifications.
- Support the development and optimization of analytical methods and protocols and ensure methods and techniques are in compliance with the PQS.
- Support Supplier Engineering for projects related to Product Adminstration kit, including Vendor Management.
- Liaison with production operation teams, R&D and Regulatory on component quality issues and supplier initiatives for the API and varithena adminstration kit components.
- Support other projects as assigned by the company.
- Deliver project status updates to senior management and project sponsors incorporating status reports and project plan updates.
- Establish and support a work environment of continuous improvement that supports the Quality Policy, Pharmaceutical Quality System and the appropriate regulations for the area they support.
- Ensure employees are trained to do their work and their training is documented.
- Life Science Bachelor’s Degree with a sound technical background
- 5 Years+ experience in pharmaceutical development and manufacturing
- Excellent understanding and hands -on working knowledge of cGMP, quality and regulatory requirements for clinical and commercial material
- Demonstrated ability to successfully manage a team for technical transfer and pharmaceutical development projects
- Valid working Visa
For further information on this role in please contact Mark Wilson on 0860449473 or email firstname.lastname@example.org
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