Bedok - Senior Manager, Quality Assurance

Tasks & Responsibilities

Key Responsibilities

Specific accountabilities include:

• Under the direct leadership of Head of RA&QA, in charge of the quality team, responsible for formulating and implementing the company's quality management system (QMS), including quality strategy, quality objectives, quality policy and quality system, and is fully responsible for Quality Assurance.
• Provide the necessary resources, reasonable planning, organization and coordination, and ensure that the quality department performs its duties independently.
• Responsible for establishing, implementing and maintaining effective operation, analysis and improvement of the company's Quality Assurance system, and responsible for reporting the operation of the Quality Assurance system to the Management Team.
• Responsible for planning and designing the company's Quality Assurance system documents, organizing and guiding the preparation of system documents, supervising and guiding the implementation of system documents, and ensuring the effective implementation of Quality Assurance system documents; Ensure that the Quality Assurance system of the enterprise is continuously improved with country regulations to ensure that the products meet the quality requirements.
• Work responsibilities:
• Approve the quality agreements signed with manufacturers and drug distributors to ensure that the drugs meet the requirements of GMP, GDP and other regulations in the production, sales and post-marketing links
• Ensure that raw materials, packaging materials, intermediate products, products to be packaged and finished products meet the requirements and quality standards approved by the registration
• Ensure the completion and supervision of the listing release review of the batch records
• Ensure that all necessary inspections are completed
• Approve process procedures, quality standards, inspection methods, and other Quality Assurance procedures
• Review and approve all quality-related changes
• Ensure that all deviations are under control and that all major deviations and inspection results exceeding the standard have been investigated and dealt with in a timely manner
• Approve and supervise commissioned inspections
• Ensure that all necessary validation work is completed, and that validation protocols and reports are reviewed and approved
• Evaluate and approve material vendors
• Ensure that all complaints related to product quality have been investigated and processed with in a timely and correct manner, hold quality analysis meetings from time to time, and report user complaints and processing results to the general manager
• Ensure the completion of the continuous stability inspection plan of the product and provide the data of the stability inspection
• Ensure the completion of the annual quality review analysis of the products held for the drug product
• Review and approve the annual plan of the company's Quality Assurance system training, be responsible for the organization and implementation of the QA system training, and oversight other departments to organize QA system knowledge training to continuously improve the QA awareness of employees; Ensure that QA personnel go through the necessary pre-job training and continuing training, and adjust the training content according to actual needs
• Responsible for the investigation, handling and reporting of major quality accidents, quality complaints, product recalls, drug safety emergencies, etc.: the authorized person in charge or personally organizes the investigation and analysis, negotiates the solution with the relevant departments, supervises the implementation of the solution, and reports the accident investigation and analysis and resolution results to the general manager in writing
• In the event of a major drug quality accident, it should be reported to the general manager and the provincial and municipal drug administrations in a timely manner
• Responsible for coordinating the cooperation of other business departments and external cooperation units of the company
• Responsible for the assessment of the personnel of the department
• Make suggestions on the organizational structure of the quality center and report to the general manager for approval; Responsible for approving the departmental responsibilities and job responsibilities of the quality center

QUALIFICATIONS / REQUIREMENTS

Knowledge/

• Bachelor of Science with at 15+ years of experience in pharmaceutical industry of which at least 10+ years of Quality Assurance, or
• Master of Science with 8+ years of Quality Assurance; or
• Ph.D. or Pharm.D. or M.D. in Sciences with least 6+ years in Quality Assurance experience.
• Should have rich experience in drug production Quality Assurance, proficient in production technology, familiar with pharmaceutical regulations, proficient in GMP, GDP, and able to carry out Quality Assurance and continuous improvement in accordance with the company's Quality Assurance system
• Excellent leadership skills, strong judgment, decision-making, planning and execution skills, good professional ethics and dedication and diligence
• Familiar with various pharmaceutical regulations, drug management regulations and customer requirements
• Proficient in enterprise Quality Assurance system documents, able to supervise implementation, conduct quality risk assessment and continuous improvement
• Familiar with product technology, quality standards and other SOPs, and able to judge whether the products produced meet the quality standards

• Project management skills, including cross-functional communication, interpersonal and influence-management skills.
• A great team player with excellent communication skills, verbal and written, and strong analytical skills
• Ability to work with QA team and project team across different locations and time-zones