The job requirements include the following essential areas of responsibilities:
Performing QA review/approval of investigation reports, change controls, Standard Operating Procedures, investigation documentation, and process/facility change control documents.
Manage and track tasks for assigned Quality projects, CAPAs, and/or Audit Response commitments, and other initiatives to assure on time completion.
Responsible for collaborating with appropriate departments to resolve both technical and compliance issues by providing Quality Assurance oversight.
Education/Certification/Experience:
Bachelors Degree, preferably in a scientific discipline (biology, chemistry or closely related field) or equivalent education/experience with a minimum of 10 years relevant progressive experience in the pharmaceutical industry.
Requires a minimum of 3 years of experience in Quality Assurance, Quality Engineering, or Compliance role within pharmaceutical industry.
Skills/Knowledge/Abilities:
Computer proficiency with comprehensive working knowledge of MS Office products, Learning Management Systems (LMS), EDMS and ERP systems, as well as Quality systems such as Trackwise.
Self-directed with ability to organize and prioritize work
Ability to communicate effectively with excellent written and oral communication skills
Ability to interact positively and collaborate with co-workers and management