QA Compliance Specialist

1. Responsible for ensuring compliance with local regulations & ISO Standards. 
2. 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. 
3. Provides general quality oversight to operations on the shop floor, supporting operators and support staff as needed to identify and address product quality and compliance issues as they arise. 
4. Perform random verifications of routine operational requirements, both on a product/batch level as well as on a process level. 
5. Responsible for driving product quality improvements by coordinating investigations and corrective actions with all operating units, QA, Site Services, and suppliers to determine root causes and corrective actions to resolve complex, compliance related issues. 
6. Support Quality Assurance with internal audit coordination, response, and follow-up activities. 
7. Evaluate current operational practices and recommend process improvements to ensure continued compliance to regulatory requirements and industry expectations. 
8. Participate in or lead internal/external audits, as needed. 
9. Ensures that all activities in his/her unit or section are done according the relevant cGMP and ISO standards.
10. Participate in the Quality Risk Management system inside the company to ensure effective identification, evaluation and controlling of the raised risks from different company processes.
11. Evaluation and decision of deviations reports in compliant with cGMP guidelines and SOPs, while escalating the decision for critical /major deviations to quality management. 
12. Actively participates in process improvement teams/initiatives. 
13. Participate in all Change Control activities; reviews and follow up.

Participate in customer complaints investigations and follow up of relevant CAPAs.