Job Title: Insource Manager/Seninor Manager Quality Assurance APAC, R&D Quality Assurance
Job Location: Mainland China, 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