Quality Compliance Unit Head

Supports day to day site Quality Compliance needs on the shop floor. Identifies and resolves Quality Compliance issues within the Process Unit unilaterally and cross-functionally. Works closely with the Process Units and Quality Organization to ensure compliance with local regulations through operational oversight. 
Assists with Regulatory Agency inspections/ activities, as needed.
1- Responsible for the following compliance systems:
a. Handling of internal audits; including planning, execution, reporting and closing of internal audits on all company processes.
b. Handling of Complaints; including evaluating, investigation and organizing the relevant CAPAs.
2- General:
a. Responsible for ensuring compliance with local regulations & ISO Standards.
b. Ensure and monitor adherence to all company policies and procedures relating to current Good Manufacturing Practices, Standard Operating Procedures and Health, Safety and Environmental Protection.
c. Perform random verifications of routine operational requirements, both on a product/batch level as well as on a process level. 
d. Evaluate current operational practices and recommend process improvements to ensure continued compliance to regulatory requirements and industry expectations.
e. Participate in or lead internal/external audits, as needed.
f. Ensures that all activities in his/her unit or section are done according the relevant cGMP and ISO standards.
g. Actively participates in process improvement teams/initiatives.