Seeking an experienced individual responsible for supporting the daily manufacturing and facility operations, along with project support. Functions include proactive support of change control assessments, documentation reviews and validation review/support. Functions also include reactive support of discrepancy identification and resolution on the floor, Investigation Team Support, TrackWise (assessing product impact), and reporting operational metrics. This function supports and communicates events to shift leadership on a daily basis.
· Bachelor's degree in a scientific discipline strongly desired.
· Minimum 5-8 years related experience in a Quality Assurance role in the pharmaceutical industry.
Technical Knowledge/Skills Needed:
· Strong written and oral communication skills.
· Thorough understanding of the regulatory process from GLP through commercial manufacturing.
· Pharmaceutical Quality Assurance experience, including the ability to identify and resolve compliance issues.
· Familiarization with oral solid dose manufacturing qualification and quality.
· Extensive knowledge of US and European Drug Product GMP requirements and associated guidelines.
· Demonstrated experience in implementation and administration of quality systems for drug product development, manufacturing and quality control operations.
· Project management experience including scheduling, tracking and auditing.
· Experience in change management and deviation resolution including CAPA systems.
· Active participation on pharmaceutical technology transfer teams and CMC team as required
· Experience with the qualification of facilities, utilities, equipment and processes.
Personal Attributes Needed:
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 increase others knowledge of US end European GMP regulations and guidance. Teacher level knowledge of GMP's. Demonstrated leadership skills with a high degree of independence and limited oversight. Demonstrated success with increasing levels of organizational responsibility.