Quality Compliance Manager

Profile Summary

Ensure that the activities carried out by the businesses in the Cileungsi Factory are compliant to all regulatory requirements for healthcare and personal care products, as described in Global Business Management System Health & Hygiene Products.

Responsibilities

•To establish and maintain implementation of quality management system in the factory. Ensuring that products and services meet all necessary standards and regulations, includes overseeing the development and implementation of quality management systems, as well as monitoring their effectiveness.

•Develop and implement a local Health & Personal care business procedure (BMS) (procedures and working practices) to meet current Reckitt Personal Care policies in conjunction with Global Quality Manual and Reckitt Global Procedures.

•Develop and maintain robust and effective system validation (protocol and report) for health and personal care in Cileungsi factory or and manufacturing line in co manufacturing according to US-FDA or PIC’s validation guidelines.

•Coordinate to set up co-manufacturing operating procedure for producing health and personal care.

•Set up and implement product recall system in the downstream business to be fully an integrated recall system from end to end business according to health care product regulated.

•Authorized to do product disposition approval for distribution purpose based on production and laboratories documentation, include CoA issued.

•Define and document a program me for ensuring implementation of Data Integrity Standard.

•Working closely with cross function to support consistency and updated all the time status as per Data Integrity Standard

•Ensuring Data Integrity Assessment is up to date all the time, with support of SME of each department.

•Providing report status of Data Integrity implementation at Cileungsi as well as evaluation to define its improvement plan

•Investigate quality issues and failures and apply Corrective And Preventive Actions (CAPA) to prevent recurrence and advise regarding CAPA necessary at country quality level for items not under local manufacturing control/produced.

•Ensure implementation of Risk Management effectiveness accordingly to global Risk Management procedures.

•Representing Quality in the cross functional health care project to ensure all health care requirement is accommodated.

•Coordinate in analyzing country product data, CAPA and post-market surveillance information.

•Co-ordinate and host external inspections by Regulatory Authorities, third parties and Reckitt.

•Co-ordinate follow ups and responses after external inspection.

•Be accountable for budgeting plan and execution to keep within agreed limits.

•Establish self and/or team member follow GMP and other regulation related to safety and environment.

Qualification:

•At least 3 - 7 years experience working in a quality assurance function in Cosmetic, Healthcare, or Pharmaceuticals related industry.

•Clear understanding and ability to assess and act upon product safety, quality, efficacy and assurance risks.

•Good understanding of regulatory and GMP requirements relevant to a regulated product e.g. EU GMP, WHO, PIC/S, CFR 21 Part 210/211,

•Have a good knowledge and understanding on GMP (Good Manufacturing Practice), Quality Management System (Deviation, CAPA, Risk Management, Change Control), ISO 9001, ISO 22716.

•Strong interpersonal and communication skills, auditing skills, and appropriate qualifications in auditing an advantage.