QA Specialist

7 days ago

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

Responsibilities

  • Ensures compliance and assist in the implementation of Quality Management System (QMS), compliance to regulatory requirements, and GxP Standards (e.g. GDSP, GMP, GCP) as applicable
  • Initiate and implement quality initiatives and programs for continual improvement
  • Provides guidance to operational areas to ensure robust quality system
  • Effectively write, review, and/or approve 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
  • Act as the Qualified Person in compliance to FDA regulations (e.g. license-to-operate)
  • Attends during regulatory inspections and customer audits
  • Develop, revise, maintain, and implement 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
  • Develop, review, and conduct Risk Assessment and Quality Risk Management activities
  • Review/Approve validation projects, plans, protocols, and reports
  • Perform quality activities related to Supplier Management such as vendor assessment and audits, as necessary
  • Act as deputy in the absence of the Quality Assurance Manager
  • Assist 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
  • Exhibit attention to detail in all areas of work
  • Display excellent and effective communication skills, both verbal and written
  • Display effective and efficient data collection, management, problem analysis, and problem-solving skills
  • Planning and organizing tasks
  • Exhibit leadership and think strategically
  • Maintain a positive attitude and intrinsic motivation when solving problems
  • Be 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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