Quality Compliance Leader

Compliance leader will play a key role in ensuring the businesses in the Cileungsi Factory are compliant to all relevant regulatory requirements, as described in Reckitt Global Business and Quality Management System.

Responsibilities

1. Develop and implement a local business procedure (procedures and working practices) to meet current Reckitt policies in conjunction with Global QA team and Regional Regulatory team.
2. Develop, coordinate, carry out, and monitor training program together with HR for factory level that are relevant according to Reckitt policies and current applicable regulations.
3. Initiate and coordinate quality culture program to enhance quality awareness level among Reckitt Cileungsi employees.
4. Support & monitor investigation process of quality issues and failures and its CAPA to prevent recurrence.
5. Maintain and monitor robust and effective Quality Management System in Cileungsi factory according to Reckitt Global procedures and applicable regulations, such as quality incident, deviation, CAPA to ensure it can be completed according to the timeline.
6. Monitor validity of third party (external lab, pest control, calibration service, etc) quality agreements to ensure its compliance with Reckitt policy.
7. Authorized to do product disposition approval for distribution purpose based on production and laboratory documentation, include CoA issued.
8. Work with Area Quality Leader (AQL) in factory to ensure implementation of appropriate controls to ensure consistent product quality.
9. Ensure Metrics Reporting for Cileungsi site are available and reported as per required timeline to relevant stakeholders.
10. Monitor & review of Globally Reportable Issues tracker from Global Metrics and initiate preventive action if necessary.
11. Support on coordinating and maintaining compliance at EMO, ensure that relevant documentation related with EMO stay up to date, such as Technical Agreement, Technical Manual, etc.
12. Support Quality Compliance Manager on quality matters related with Reckitt products that manufactured in the EMO, including complaint, deviation, OOS, CAPA, audit, change control, risk management, etc.
13. Ensure Metrics Reporting for EMO site are available and reported as per required timeline to relevant stakeholders.
14. Supporting in coordination and hosting external inspections by Regulatory Authorities, third parties and Reckitt, including managing CAPA feedback and tracking the closure.
15. Supporting on coordination of self-inspection including planning, appointing auditor and maintaining process to be aligned with RB and related Authority standard, managing CAPA feedback of cross department and tracking the closure.

Qualification:

1. Minimum holds a bachelor’s degree in pharmacy, biology, chemistry, chemical engineering, or any related scientific field.
2. Having 3 years of experience working in a quality assurance function in Healthcare, Pharmaceutical, or Medical Device related industry.
3. Knowledge of regulatory and GMP requirements relevant to a regulated product e.g. EU GMP, WHO, PIC/S, CFR 21 Part 210/211.
4. Knowledge on quality system such as: ISO 9001: 2015, ISO 22716:2007, etc.; audit management.
5. Proficient on Quality Management System Handling such as Audit Management, Deviation Management, CAPA Management Recall handling, etc.
6. Computer Literate and able to use Microsoft Office Applications, such as Word, Excel, Power Point.