Job Description

Job Title: Insource Seninor Manager Quality Assurance APAC, R&D Quality Assurance

Job Location: Taiwan or Malaysia

Our mission in Quality Assurance is to achieve enduring excellence in auditing, quality management, quality risk assessment and enhance the R&D quality mindset for the benefit of our patients.

The job holder is responsible for:

·Planning, leading, conducts and reports audit activities for R&D GxP risk-based audit programs

·Support of GxP inspection activities

·Management of CAPAs related to audit and/or inspection findings in collaboration with QA colleagues and functions owning the issues.

Responsibilities:

Audit

·Plans, leads, conducts and reports audits in assigned GxP areas, such as investigator site and/or project audits

·Supports lead auditors in the planning, conduct and reporting of more complex audits such as Process / System, External supplier

·Works with contract personnel or consultants to prepare, conduct and report outsourced audits

CAPA

·Assesses need for, and assists in development of CAPA plans, approves and monitors plans to completion for assigned audits

·Assists with the continuing follow-up of agreed audit CAPA actions from across QA to assist in the monitoring of QA Key Performance Indicators

General Accountabilities

·Ensures own tasks are performed to current practices and in accordance with company policies, standards, SOPs and guidelines

·Promotes a culture of ethics, integrity and continuous improvement that focuses on delivering efficiencies and planned business benefits

·Communicates effectively with QA colleagues and business stakeholders

·Maintains knowledge of relevant industry information affecting quality and compliance arena

·May provide responsive and proactive quality and compliance advice to defined customers.

·Support quality and compliance risk management for functional area using risk framework standards to define risk and develop mitigation recommendations

Travel expected

Requirements:

Essential

·Degree level education or equivalent experience

·Experience in pharmaceuticals or a related industry

·Excellent analytical, written and oral communications skills

·Fluent in written and spoken English

·High ethical standards, trustworthy, operating with absolute discretion

·Collaborative, influencing and interpersonal skills – curious to understand business environment

·Skilled at managing & using technology

·Ability to develop professional networks with stakeholders

Desirable

·Audit Experience

·Supplier qualification

·Experience of regulatory health authority GxP Inspections