Senior QA Associate

Job Details

Job Type
Anissa Low
about 1 year ago
The Senior Quality Assurance Associate is responsible for the management of all quality assurance functions associated with the company’s Secondary Packaging Unit; APAC warehouse facilities located in Singapore & Hong Kong and APAC contracted 3PL’s, ensuring these functions are implemented and performed in compliance with company policies, ISO, GDP and GMP requirements and as required by local licensing authorities.
Change Control
  • Evaluate and classify all proposed changes affecting the Quality Management System
  • Lead role in the Change Control Board meetings
  • Track the implementation of all changes against agreed Change Control Action Plans
Quality Risk Management
  • Apply the principles of Quality Risk Management with respect to Premises, Equipment, Computerised Systems, Processes, Qualification and Transportation
  • Identification, assessment, control, communication and review of risks to the quality of medicinal products
Investigation and Reporting Deviations
  • Record and classify all deviations from written instructions, requirements of GDP and GMP or an unexpected event
  • Investigate all deviations and record root cause, impact assessment and trend analysis
  • Identify corrective and preventive actions, as well as system improvements
  • Ensure corrective action is implemented in a compliant and timely manner
Document Control
  • Create, control and maintain documentation and formal systems to safeguard the Company’s data records
  • Develop and maintain the SOP’s and other controlled documents
  • Ensure Forms, Policies and SOP’s are kept up to date and are easily accessible by all staff
  • Develop and periodically review the processes and documentation of the Quality Management System
  • Supply quality documentation to partners and relevant government agencies
Training Activities
  • Provide training to relevant company employees in the Code of GDP, GMP, SOP’s and other necessary procedures
  • Maintain training records
  • Participate in internal & external training as required, to ensure Quality Assurance practices are up to date and compliant with best practice and legislation requirements
  • Organise and perform internal compliance inspections.
  • Ensure all facilities are appropriately licensed and the company personnel adhere to appropriate local regulations
  • Inspection of Packaging / labels / printed materials
  • Authorise release of incoming stock after determination of compliance
  • Inspection of returned goods
  • Maintain and review complaints database
  • Log all entries and process responses, coordinating with Med Info and Customer Service if required
  • Customer complaints & returns
  • Segregation and reconciliation of rejected stock
  • Undertake special projects and investigations as defined by the company
  • Ensure filing and documentation is up-to-date and is compliant with standard processes and formats
  • Complete required reports within designated timeframes
  • Participate in meetings as needed
  • Liaise with management and staff to ensure projects are conducted efficiently
  • Communicate with staff & management using proper channels
  • Master computer skills and required software programs
Knowledge and Compliance
  • Ensure all authorised written procedures are followed accurately and report any deviations to the Compliance and Commercialisation Director
  • Assist in identifying and solving compliance issues within the Company
  • Maintain high standards of cleanliness, tidiness and organization of work areas
  • Ensure the facilities are appropriately licensed and the company adheres to appropriate local regulations and company standards
  • Maintain a current and comprehensive knowledge of competitors and general products
  • Attend relevant industry conferences to expand knowledge of relevant therapeutic areas
  • Understand the issues affecting the customers who prescribe our products and patients who use them
  • Promptly notify pharmacovigilance unit of all adverse reactions reported on products
  • Maintain up-to-date knowledge of industry trends, cutting-edge practices and techniques, current publications, regulations, etc.
  • Maintain up-to-date knowledge of standard operating procedures and policies and ensure compliance at all times
  • Ensure your Company related activities comply with relevant Acts, legal demands and ethical standards
  • Minimum 5 years of experience in quality assurance within the Pharmaceutical industry
  • Significant experience of secondary packaging processes
  • Significant experience of working within a GDP and GMP Quality Management Systems, an understanding of facility design and operations, and experience in staff training are highly desirable
  • Auditing experience
  • Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
  • Tertiary qualifications in Science or technical discipline
License No. 17C8975