Pharmaceutical Quality Analyst
1 week ago
Responsibilities:
- Manage and track tasks for assigned Quality projects to assure on time completion for CAPAs and effectivity verification, Quality improvement programs, and other initiatives.
- Support internal audits and walk-throughs conducted by the Quality Compliance department and related follow up actions/activities.
- Authoring and reviewing standard operating procedures, forms, checklists, protocols, risk assessments and other types of GMP documents.
- Responsible for collaborating with appropriate departments to resolve both technical and compliance issues related to Quality management system elements.
- Support execution of protocols, gather data and inputs and write related reports.
Qualifications:
- Bachelor’s Degree, preferably in a scientific discipline (biology, chemistry or closely related field) or equivalent education/experience with a minimum of 7 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.
- Experience with GMP.
- Experience with CAPA.
Skills:
- 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
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