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  • 3 weeks ago

jobs description

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Job Description

Primary Purpose of the Job

The Quality Assurance Manager is responsible in ensuring that all quality related activities of Takeda Healthcare Philippines, Inc. are in compliance with the local regulatory and statutory requirements in the conduct of its business. In addition, the job required the person to assure and maintain the quality of products and processes, including standard procedures, quality audits/review.

Key Responsibilities and Accountabilities
• Implement Takeda QMS and ensure on-going compliance with quality standards and procedures.
• Implement the Quality Plan in Philippines.
• Ensure Quality Council is... conducted at the LOC.
• Provides Supplier Quality Management and oversight in accordance with Takeda Supplier Quality Management requirements. These would encompass the selection & qualification of new suppliers, ongoing quality performance monitoring and exit of suppliers which provide materials and services with GxP/product quality impact. Ensure new GxP suppliers/contractors are audited and qualified before use. Lead or participate in quality audits, & support QA due diligence of new business partners according to local regulatory requirements
• Accountable and oversee the management of local Quality activities to support Quality operations. Quality activities include but not limited to: product release, complaints handling, deviations, change controls self-inspection, trainings, control of GxP documentation, quality risk management, in-country testing requested by health authority, support new product launches, quality oversight of local GMP/GDP activities etc.
• Local release: Ensure batch release is in compliance with local regulatory requirements and local procedure prior to distribution.
• Evaluate returned goods and ensure that damaged and expired materials are properly destroyed
• Checks the quality of packaging materials, from artwork development up to the finished product
• Organizes / partakes in internal audits (self-inspection) in cooperation with other functions
• Ensures that changes with impact on quality, safety, and registration status of products are being reviewed, approved, and authorized prior to implementation
• Ensure all relevant LOC colleagues performing GxP quality-related tasks are appropriately trained prior to performing activities.
• Ensures proper documentation and archiving of QMS documents, along with maintaining traceability
• Ensures gap assessment on global procedures applicable to the LOC is being done timely
• Reviews adverse event reporting made by the Pharmacovigilance team monthly by conducting random check
• Performs other tasks and duties which may be assigned by the immediate supervisor from time to time
• Provide quality expertise and resolution of all product quality issues originating in the LOC in conjunction with other functions (ie. Regulatory Affairs, Medical, Business Unit, GMS). Timely escalation of reportable events in accordance with Takeda Global process.
• Participate and lead the implementation of integrated GxP enterprise systems.
• Influence LOC Quality strategy cascaded from Global Quality Roadmap and align to LOC Business Plan.
• Drive and strengthen the Quality Culture

Good Manufacturing Practice
• Audits third party distributors and suppliers, ensuring adherence to GMP / GDP, QMS, and regulatory requirements
• Supervise testing methods and repackaging of products as approved by FDA and ensures compliance with GMP and ASEAN requirement of toll manufacturers

Strategic Planning
• Undertake QA activities in accordance with agreed business priorities to optimize commercial success for the business.

Patient-Centricity
• Provide QA support to internal stakeholders as expected in Takeda’s global standard operating procedures (SOPs) and policies

People Management
• Contribute toward building a performance-based culture that leads to operational excellence within the QA Department
• Promote teamwork and boost overall team morale

Corporate Governance and Quality Management System
• Comprehend and drive Takeda’s operational procedures and policies
• Create and implement departmental standard operating procedures for QA activities and ensure compliance with relevant corporate / department policies / procedures
• Support internal/external audits and implementation of corrective actions when applicable
• Maintain up-to-date knowledge of Takeda’s standard operating procedures and guidelines
• Ensure timely training of applicable SOPs and retain training records

External Stakeholder Management
• Participate in local authority inspections and internal audits, as applicable
• Foster strong working relationship with local regulatory authority to ensure optimal stakeholder management and LOC support

Cross-functional Collaboration
• Cultivate excellent working relationships with other departments (in particular commercial, medical affairs, market access, pharmacovigilance, supply chain, compliance, legal and finance) and senior management

11 Qualification Requirements
• Bachelor of Science Degree in Pharmacy or Industrial Pharmacy
• Pharmacy professional license holder
• A minimum of 5 years of relevant QA expertise in the pharmaceutical industry

Competencies Required
• Demonstrated leadership and strategic planning skills
• Performed successfully within a team environment and as an individual contributor with the ability to work in a matrix environment
• Proficient practical application of QMS knowledge to drive improvements
• Strong understanding of linkages and interrelationships between different QMS elements, and able to effectively integrate quality data sources
• Good knowledge of ICH Q10 requirements, and application to LOC operations (CC, QMR, Deviations, CAPA, Knowledge Management, Management Review etc
• Ability to communicate effectively with senior management
• A mind-set of continuous improvement, innovation and be solution-focused with strong problem-solving ability
• Ability to assess and make risk-based decisions while keeping stakeholders appraised
• Experienced in assessing a situation, identifying issues and developing solutions that result in efficiencies or process improvements
• Ability to work with a sense of urgency, prioritize work, meet objective / deadlines with strong organizational capability
• A sense of commercial acumen and have met department goals within specified timelines
• Excellent negotiation, project management, verbal and written communication skills in English
• Knowledge in local regulations regarding Licensing
• Background in Good Manufacturing Practices
• Microsoft Office Skills (in particular MS Word, MS Excel, MS PowerPoint)
• Ability to plan, organize and prioritize

This job description defines and captures key expectations. However, duties and / or roles are not limited to details above and may evolve or change during the course of the role based on the company priorities and manager’s discretion.

As with all Takeda positions, the Quality Assurance Manager is expected to conduct self in line with the company culture and Takeda-ism.

Locations

Manila, Philippines

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
Manila Metro Manila Philippines

salary-criteria

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