Essential Duties & Responsibilities
Key responsibilities of the position include, but are not limited to –
- Responsible for the oversight, reporting and monitoring of company's quality systems, including investigations, corrective actions (CAPA), training programs.
- Responsible for the improvement of existing systems and the development of new quality systems.
- Assist all departments in the generation of quality system documentation; such as, SOPs, deviation/investigation reports, equipment/system qualification protocols and reports, and change controls.
- Quality release of raw materials and finished products.
- Coordinate and Participate in quality investigations (including OOS investigations); work with impacted functions in the development of required CAPA items.
- Coordinate submission of samples for QC analysis.
- Administration of Kashiv stability program – protocol review, stability set-up, environmental chamber monitoring, etc.
- Administration of Kashiv change control system.
- Review and approval of manufacturing and packaging master and executed batch records.
- Provide QA support during manufacturing and analytical operations.
- Audits: Perform internal and external (vendors/facilities) audits.
- Interface with customers to resolve quality issues.
- Performs other functions as required or assigned
- Complies with all company policies and standards
- Prepare and execute Quality meetings on regular basis