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.
Qualifications:
- Bachelor's degree in a scientific discipline strongly desired.
- Minimum 4-8 years related experience in a Quality Assurance role in the pharmaceutical industry.
Regards,
Sara Almas Khan | Technical recruiter
INTELLECTT INC | Healthcare & IT Consulting and Staffing Company
517 Route 1 South, Suite 1115, Iselin, NJ 08830