Job Description:
Job Title: Insource Manager/ 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
