Quality Assurance Manager

Manger of Quality Assurance

 

About the Company:  CreoSalus, Inc. is a peptide based drug development and manufacturing company. The Company is in the process of developing two NADA?s one of which is close to market launch. Our current growth and expansion includes a position for an individual who can manage all aspects of our quality assurance operations. The following is a listing of some of those duties:

 

?  Providing expertise to the Pharmaceutical Sciences & Manufacturing team, and cross functional project teams, in all aspects of quality assurance operations pertaining to development of drugs for world-wide registration.

?  Execution and management of a CMC quality master plan.

?  Review and approval of manufacturing batch records, validation plans, specifications and other GMP documentation.

?  Writing, reviewing, and approving SOP's and other related documentation.

?  Disposition materials for human use and auditing of regulatory documents.

?  Developing and/or improving existing QA infrastructure as it relates to execution of CMC activities and systems to ensure compliance with all cGMP's.

?  Authoring and approving SOP's and change control documents as necessary.

?  Auditing of third party suppliers and internal systems.

?  Provision of GMP training programs to personnel.

?  Presenting CMC Quality Assurance updates to management and project team leaders in a matrix product development team structure.

?  Working as part of a multi-disciplinary team to ensure development of safe, effective medicines in a timely and cost effective manner.

 

 

The ideal candidate will have the following qualifications:

 

Manager: Minimum of a BSc or MSc in pharmaceutical sciences, chemical engineering, chemistry or a related discipline with combined experience of at least 10 years in pharmaceutical product development and/or quality assurance. Must have a thorough understanding of cGMP and will be the interface between the Company and the FDA. Knowledge of manufacturing of peptides and their applications as pharmaceuticals is a plus.

 

We reward our employees with a competitive salary and benefits package. This position also allows the candidate to participate in the Company stock option plan.