3 months ago
We are seeking for an experienced Quality Assurance professional to join the team as Senior Manager Quality Assurance. This opportunity presents a unique challenge to leverage the well-established heritage of these drugs while simultaneously building a new, unique culture focused on growth, profitability, and long-term vision. You will have a unique opportunity to work in a start-up type environment where your position will be broad, communication between departments is fast and effective and you will have significant responsibility and autonomy for your work and contribution.
The Sr. Manager QA will support the QA Director.
The main responsibilities are:
*cGMP compliance of pharmaceutical production of API, Bulk Drug Product and Finished Product at the external outsourced manufacturing facilities;
*Technology transfer and validation documentation;
*cGDP compliance of pharmaceutical product distribution; and
*The maintenance of a functional and inspection ready internal Quality System.
*Work across all functions to ensure that Quality standards are maintained within the Company
*Provide quality guidance to product development / tech transfer projects
*Maintain the documentation system by co-writing and updating quality assurance policies and procedures
*Propose Risk Evaluation tools and Mitigation Strategies
*Write/review/approve analytical methods (transfer and validation) protocols and reports
*Write/review/approve process validation protocols and reports
*Approve supplier's CAPAs and deviation reports, change controls, complaints
*Review and approve batch documentation and transportation records according to GMP/GDP
*Support GMP/GDP vendor auditing program
Required Background and Skills:
* A minimum Master Degree in a scientific field (Pharmacy, Chemistry, Biology)
* A minimum of 10 year's experience in pharma/biotech industry (manufacturing, QA/QC) of which a minimum of 5 years in QA
* Previous operations experience in a manufacturing facility of solid dosage forms and/or injectable is considered a strong plus
* Previous experience in of Technology Transfer Projects as part of Manufacturing and/or QA Team
* Team player and excellent communication skills