- Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
- Participates in developing Standard Operating Procedures to ensure quality objectives are met.
- Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
- Reviews routine manufacturing, environmental monitoring and quality control data for in-process and finished products.
- Develops solutions to more complex problems and identifies deviations from accepted practice and evaluates impact assessment as required.
- Works directly with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
- May facilitate external audits/inspection processes, supporting implementation of corrective actions as agreed.
- Participates in the writing of annual product reviews.
- May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.
- Works with Research and Development during new product start-ups, and identifies routine checkpoints for new products and processes.
- May assist with compliance audits as required.
- Interfaces with contract manufacturers to address documentation and compliance issues.
- Writes and/or implements changes to controlled documents (e.g., SOPs, specifications, methods, etc.) as needed.
- Normally receives no instruction on routine work, general instructions on new assignment
- Min 7 years of experience
- No necessarily all in QA
- Operations and some QA is good
- Experience with CAPA
Feel free to forward my email to your friends/colleagues who might be available. We do offer referral Bonus.
Thank you.
Kind Regards,
Harris Kaushik
Clinical Recruiter
Integrated Resources, Inc.
IT Life Sciences Allied Healthcare CRO
DIRECT # - (732)-844-8715
Gold Seal JCAHO Certified ™ for Health Care Staffing
“INC 5000’s FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)
