This role is responsible for supporting the daily activities related to manufacturing operations and quality systems.
Key Duties:
Issuance of GxP documentation.
Document Management System Support.
Support documentation lifecycle (Document Scanning, Verification, Retention, and Destruction).
Develop Standard Operating Procedures and other quality related documents.
Evaluation of executed documentation (logbooks, controlled forms, and other documentation).
Support area initiatives and projects.
Skills / Abilities:
Experience in Pharmaceutical Quality Assurance, including the ability to identify and resolve compliance issues.
Ability to increase others knowledge of US end European GMP regulations and guidance.
Strong written and oral communication skills.
Experience in support of quality systems for drug product manufacturing and quality control operations.
Working knowledge of US Drug Product GMP requirements and associated guidelines.
Personal Attributes:
Team Player committed to quality; motivated self-starter; detail and results oriented; Well organized, efficient worker with good communication skills; innovative thinker and problem solver; flexible and can embrace change; can manage multiple duties and tasks.
Ability to utilize knowledge and interpersonal skills to provide leadership, direction and development of others.
Good computer skills.
Good work ethic, dependable, punctual, and flexible.
Good motivator of personnel.
Good team player with a can-do attitude.
Can get things done on the basis of influence.
Can work in a fast-paced environment with multiple issues open simultaneously.
Highly organized.
Attention to detail.
Identifies opportunities to improve and contributes to problem solving.
Education:
Requires a Bachelor's degree in a scientific discipline or equivalent experience.
Experience:
0-2 years' experience in a Quality Assurance role in the pharmaceutical industry.