Sr Manager Quality Assurance

Company
Volt
Location
Switzerland
Salary
Negotiable
Posted
09 Aug 2019
Closes
08 Sep 2019
Ref
74314-PHARM-DEB
Contact
Denise Saab
Discipline
Quality, QA / QC
Hours
Full Time
Contract Type
Permanent
Experience Level
Senior Management
We are proudly partnering with a global special pharmaceutical company that markets therapeutic solutions for patients with life-threatening conditions and chronic illnesses. The company has global commercial, business development, product supply chain, product development, quality and regulatory functions based in Zug, Switzerland.
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

Apply for Sr Manager Quality Assurance

Already uploaded your CV? Sign in to apply instantly

Apply

Upload from your computer

Or import from cloud storage

Your CV must be a .doc, .pdf, .docx, .rtf, and no bigger than 1MB


4000 characters left

Marketing Communication

We'd love to send you information about Jobs and Services from PharmiWeb.jobs by email.

All emails will contain a link in the footer to enable you to unsubscribe at any time.


When you apply for a job we will send your application to the named recruiter, who may contact you. By applying for a job listed on PharmiWeb.jobs you agree to our terms and conditions and privacy policy. You should never be required to provide bank account details. If you are, please email us.

Similar jobs

Similar jobs