Quality Assurance Specialist

5 days ago

Cavite City, Philippines 101 Supply Chain Solutions Inc. Full time

Ensures compliance and assists in the implementation of Quality Management System (QMS), compliance to regulatory requirements, and GxP Standards (e.g. GDSP, GMP, GCP) as applicable

Initiates and implements quality initiatives and programs for continual improvement

Provides guidance to operational areas to ensure a robust quality system

Responsibilities
  • Effectively writes, reviews, and/or approves documented procedures (e.g. SOPs, Work Instructions, Protocols, etc.) to ensure quality assurance attributes are met
  • Ensures proper documentation and archiving of QMS documents, along with maintaining traceability
  • Acts as the Qualified Person in compliance to FDA regulations (e.g. license-to-operate)
  • Attends during regulatory inspections and customer audits
  • Develops, revises, maintains, and implements Quality Assurance policies, programs, and procedures
  • Conducts training of Quality Assurance related policies, programs, and procedures
  • Performs quality related tasks including but not limited to processing, reviewing, and documenting internal audits, change control, deviation/non-conformances, CAPA, Management Review, among others
  • Ensures that product and process deviations, non-conformities, complaints, recalls are reported, investigated, resolved, and documented properly
  • Develops, reviews, and conducts Risk Assessment and Quality Risk Management activities
  • Reviews/Approves validation projects, plans, protocols, and reports
  • Performs quality activities related to Supplier Management such as vendor assessment and audits, as necessary
  • Acts as deputy in the absence of the Quality Assurance Manager
  • Assists with Quality Assurance Department functions as needed
  • Performs other tasks and duties which may be assigned
Qualifications
  • Bachelor’s degree in pharmacy, chemistry, chemical engineering, and other science-related courses
  • Must be licensed
  • In-depth knowledge of Quality Management System, Regulatory Requirements, and Good Industry Practices (e.g. Good Storage and Distribution Practices, Good Manufacturing Practices, Good Clinical Practices)
  • Computer literate with basic knowledge in MS Office
  • Exhibits attention to detail in all areas of work
  • Displays excellent and effective communication skills, both verbal and written
  • Displays effective and efficient data collection, management, problem analysis, and problem-solving skills
  • Planning and organizing tasks
  • Exhibits leadership and thinks strategically
  • Maintains a positive attitude and intrinsic motivation when solving problems
  • Is productive, organized, and able to manage deadlines
  • Has the ability to adjust to changing regulations, new products, new process, and/or technologies
  • Has the ability to prioritize projects appropriately, work with complex timelines, and meet department objectives
  • Has the ability to manage multiple projects while maintaining high quality outcomes
  • Ability to work proactively with workmates, both superiors and subordinates
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