
Sun Pharmaceutical Industries Ltd
Designation : Manager
Reporting To : Associate Director, Corporate Quality Compliance and Policies
Function : Corporate Quality Compliance and Policies
Functional Area : Quality Compliance
Job Role Summary : Implementation of Global documents at sites globally post deployment, Monitor progress of commitments regulatory bodies and consultantsÂ
Job Profile :
- Monitor, generate and report on metrics on implementation of Global documents at sites globally post deployment
- Meet with and discuss implementation status with regulated market site representatives in order to direct implementation, facilitate implementation and guide sites to overcome hurdles in implementation as requiredÂ
- Support the CQC&P team to ensure that target dates for updates on Global document implementation to regulatory bodies, e.g. FDA, are met by timely preparation and site data collection
- Monitor progress of commitments made to regulatory bodies and consultants for Global document creation/revision to ensure that deadline dates are not exceeded
- Support the upgrade/enhancement of enterprise electronic systems by ensuring timely communications to aid site preparedness, e.g. notification of approved status of system GSOPs, Â to enable alignment of site readiness to Go-Live target dates
- Execute projects and initiatives to enhance processes, compliance and the Global document collection e.g. review of site implementation of Global documents and site practices, reduction/simplification/enhancement of Global documents
- Carry out effectiveness checks of Global document implementation e.g. performing spot checks on site/function procedures to assess alignment against the requirements in the Global Documents
Job Requirements :
- Minimum of five (5) years of experience within the pharmaceutical industry in quality function role.
Experience working in an international multicultural matrix organization.
- Excellent interpersonal and communication, both written and verbal, skills.
- Strong organizational and time management skills; must be able to prioritize and manage multiple assignments simultaneously while working independently or with others as needed.
- A self-starter with a hands-on approach and a can-do attitude.
Work / Job Experience : 5 Years
Type of Experience : CQC&P
Academic Qualifications :
Minimum of Bachelor’s degree.