QA Specialist

101 Supply Chain Solutions Inc.; Cavite City; On-site; PHP 334,800 - 502,200; Full time

Job summary

A leading supply chain solutions provider in Cavite City is seeking a Quality Assurance professional to ensure compliance and implement quality management systems. The ideal candidate will hold a Bachelor's degree in pharmacy or a related field, be licensed, and possess strong skills in communication, problem-solving, and leadership. This role involves guiding operational areas, conducting training, and maintaining documentation in line with regulatory standards.

Qualifications

• In-depth knowledge of Quality Management System and Regulatory Requirements.
• Must exhibit excellent communication skills, both verbal and written.
• Ability to manage multiple projects and meet deadlines.

Responsibilities

• Ensure compliance with regulations and GxP standards.
• Guide operational areas in maintaining a robust quality system.
• Conduct training on Quality Assurance policies and procedures.

Skills

Attention to detail

Effective communication

Problem analysis and solving

Leadership

Planning and organizing

Education

Bachelor’s degree in pharmacy or related field

Licensed professional

Tools

MS Office

Job description

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