Insource TOP MNC- Seninor Manager R&D Quality Assurance APAC

1 week ago

Kuala Lumpur, Kuala Lumpur, Malaysia Caidya Full time $80,000 - $120,000 per year

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

Job Location:
Taiwan or Malaysia

Job Overview:

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

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