Specialist, Quality Assurance

Title: Specialist, Quality Assurance

Location:

Taguig, PH, PH

Global Business Unit: HEC

Job Function: Regulatory Services

Requisition Number: 168839

Description

Summary:

The QMS Specialist will ensure the implementation, maintenance, and continuous improvement of the Quality Management System (QMS) in accordance with regulatory requirements, industry standards, and company policies

• QMS Development and Maintenance:
• Develop, implement, and maintain QMS procedures, policies, and documentation.
• Ensure alignment with regulatory requirements (e.g., GDP, GMP, FDA, EMA).
• Quality Assurance and Compliance:
• Conduct internal audits and assessments to ensure compliance with QMS and regulatory requirements.
• Identify and address deviations, non-conformities, and corrective actions.
• Training and Awareness:
• Develop and deliver training programs for employees on QMS policies, procedures, and regulatory requirements.
• Ensure awareness and understanding of QMS principles throughout the organization.
• Ensure training is executed as required for SOP revisions.
• Monitor training completion rate, provide reports and trending accordingly.
• Continuous Improvement
• Analyze data, identify areas for improvement, and propose corrective actions.
• Change Control
• Collaborate with departments to implement changes and enhancements.
• Documentation and Record-Keeping:
• Maintain accurate, complete, and controlled QMS documentation.
• Ensure compliance with document control procedures.
• Control the creation, revision, approval, and distribution of all documents and records related to the quality management system.
• Implement procedures for document and record retention, accessibility, storage, retrieval, and disposal.
• Ensure that documents and records are accessible to those who need them and stored in appropriate conditions to prevent damage or loss.
• Vendor Management:
• Collaborate with suppliers, contractors, and third-party logistics providers to ensure QMS compliance.
• Conduct supplier audits and assessments as needed.
• Customer Complaints and Feedback:
• Investigate and address customer complaints related to quality.
• Implement corrective actions and preventive measures.
• Other QA responsibilities:
• Support manager in managing day-to-day operating expenditures against operating budgets to ensure efficient usage of resources;
• Support the implementation of quality policies, procedures and standards to ensure alignment to global DKSH quality policy and local/international quality standards;
• Provide constructive recommendations to enhance policies, practices and processes related to quality assurance (QA), safety, health & environmental (SHE) and registration (REG);
• Support external audits from suppliers and other regulatory bodies;
• Other tasks to support proper execution of quality management systems.
  
  

Functional Skills And Knowledge

• Demonstrate good knowledge of ISO 9001:2015 requirements.
• Demonstrate proficiencies in office productivity tools (e.g. MS SharePoint, MS Word and Adobe Acrobat)
• Demonstrate appreciation and respect for cultural sensitivities especially in cross-country/-cultural interactions.
• Demonstrate fluency in local language and ideally in English, both written and spoken
  
  

Soft Skills

• Experience in coordinating with cross-functional teammates
• Excellent organizational and communication skills.
• Attention to detail and accuracy.
• Experience in conducting training or communicating change.
• Education:
• Bachelor's degree in Pharmacy, Quality Assurance, or related field.
• Experience:
• Minimum 3-5 years of experience in pharmaceutical quality assurance, regulatory affairs, or QMS.
• Experience in warehousing and logistics operations desirable.
• Knowledge and Skills:
• Strong understanding of GDP, GMP, FDA, and WHO regulations.
• Familiarity with QMS standards (ISO 9001, ISO 13485).
• Excellent analytical, problem-solving, and communication skills.
• Ability to work in a fast-paced environment.
• Certifications:
• Certified Quality Auditor (CQA) preferred.
  
  

Work experience Preferably with experience in Pharmaceutical or Healthcare industry

Requisition Number: 168839

Job Function: Regulatory Services